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Previous Speakers

Christoph Volpers

Christoph Volpers

Michalski Hüttermann & Partner Germany

Arthur G Cook

Arthur G Cook

ZS Associates USA

Kamali Chance

Kamali Chance

Quintiles Inc., USA

Stanley Seung Suh Hong

Stanley Seung Suh Hong

Celltrion Healthcare Co. Ltd. South Korea

Ulrike Konrad

Ulrike Konrad

Protagen Protein Services Germany

Tim Demuth

Tim Demuth

Sandoz Pharmaceuticals GmbH Germany

András Guttman

András Guttman

University of Pannonia,Hungary SCIEX USA

Rosa Helena Bustos

Rosa Helena Bustos

University of La Sabana Colombia

Euro Biosimilars 2018

Welcome Message

Session/Tracks

11th European Biosimilars Conference organizing Committee invites you to attend the largest assemblage of biologics and biosimilars researchers from around the globe during April 26-27, 2018 Rome, Italy

Track 1: Current Challenges in Developing Biosimilars

The development of biologics calls for overcoming lot many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to quality by design (QbD).

This Euro biosimilars conference will look at the multiple facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands; 13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018 at Glasgow, UK.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 2: Emerging Biosimilars in Therapeutics

The explorations in the field of biologics have created a new avenue for the clinicians towards better disease management. The emerging biologics   have already manifested fruitful outcomes in treatment of ailments like those of psoriasis, rheumatic arthritis, certain cancers, inflammatory bowel disease (IBD) etc.

Emerging Biosimilar insulins are likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. The main theme of this track is to have sound knowledge in the emerging biosimilars like Recombinant blood products, therapeutic proteins, vaccines, Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; 10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands.

5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Track 3: Analytical Strategies for Biosimilars

Analysis of biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. Bioanalytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility.
This biosimilars global event also includes Bioanalytical methods, FormulationBioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany.

Conference on Supply Chain Security and Management October 24-26, 2018 at Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018 at Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018 at London, UK.

Related Societies:

Societies in USA: American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP),  Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC).

Societies in Europe: Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS).

Societies in Asia and Pacific: Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS).

Track 4: Regulatory Approach of Biosimilars

Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars  regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. European Biosimilars Congress 2017 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics with a clear picture of the regulatory approach for biosimilars and biologics.  The Patient Protection and Affordable Care Act (PPAC Act) was signed into law in March 2010 in addition to the amendments in the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biosimilars and follow on biologics.  These new statutory provisions are often referred as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This track concentrates upon such legal bindings and the aspects of the BPCI Act that pertain to the biosimilars and biologics. This session on legal issues shall be very beneficial to research scientists from both academic backgrounds and also those from industry R&D. The Europe biosimilars, US biosimilars, Australian biosimilars, Canada origin biosimilars and UK biosimilars are expected to take control over the biosimilar market around the globe by 2017.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

4th Antibiotics Conference; June 14-15, 2018 at Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 at Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018 at Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy.

Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany.

Related Societies:

Societies in USA: American Society of Health-System Pharmacists (ASHYP),  Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT).

Societies in Europe: Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF).

Societies in Asia and Pacific: Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA).

Track 5Biosimilar Companies and Market Analysis

The U.S. takes the lion's share (49 percent) of the global biologics market value and generates half of the sales value growth as well. The EU accounts for 22 percent of the market's sales value and 14 percent of its value growth. In contrast, emerging markets represent just a sliver of the sales pie, with 7.5 percent share. Thus, biologics market growth is still largely driven by mature markets. The global biologics market had reached $170 billion in sales value in 2012, accounting for 18 percent of the overall market. The five top 10 global products in terms of sales volume are biologics, wherein 2008 it was just two.

The market in the APAC region for biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference at June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain.

Pharmaceutical Technology Meeting, March 19-22, 2018 at Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018 at Glasgow, UK.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 6: Innovative Approach for Biosimilars

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original biosimilar innovator products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session shall be highly beneficial for the biosimilar manufacturers. This session also finds place for all the biosimilar exhibitions associated with the field of biosimilars and biologics.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK.

5th Biosimilars and Biobetters Conference April 16-17, 2018 at London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Track 7: Clinical Development of Biosimilars

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx PK/PD studies, Toxicological studies and Aspects of genotoxicity tests.Clinical trials are designed in stages I-IV so as to receive a clear picture of the drug candidate in respect to its pharmacokinetics and pharmacodynamics parameters.

Research estimates that there are 280 Biosimilars in the pipeline, and clinical trials are increasing by 20% per year.Biologics also represent over 40 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain.

Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK.

Related Societies:

Societies in USA: American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC).

Societies in Europe: Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS).

Societies in Asia and Pacific: Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS).

Track 8: Consequences of Brexit on Biosimilars

With Europe that paved way to the uptake of biosimilars over a decade ago, the consequences of Brexit would be potentially harder on UK. Presently UK is no more bound to follow the guidelines of EMA. Also research grants from Innovative Medicines Initiative and Horizon 2020 would no more be available to UK. All the same, EMA has its headquarters in London, UK. The thus arising complications would definitely have certain consequences on the Biosimilars scenario in UK and EU.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 at Berlin, Germany.

Related Societies:

Societies in USA: American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT).

Societies in Europe: Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF).

Societies in Asia and Pacific: Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA).

Track 9: Intellectual Property Rights

The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR.

The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 10: Globalization of Biosimilars

This track discuses about the generic drugs impact on global biosimilar market and Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars.

Those who can attend the biosimilar meeting under this track are ones following Biologics/ Proteins/Biosimilar Products, New Biosimilar Development, Process Science, Biosimilar Market, Portfolio Management, Research & Development, Business Development, Business Operations and Scientific Affairs.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands; 13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Track 11: Bioequivalence Assessment

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx PK/PD studies, Toxicological studies and Aspects of genotoxicity tests. This track is designed for those who are having sound knowledge on clinical studies and clinicians prospects for biosimilars. Biosimilar guidelines on the above mentioned topics are also to be thrown light upon at this biosimilars conference.

Related Conferences: Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands.

5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 12: Biosimilars Research Pipeline

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original  products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the biosimilar exhibitiors associated with the field of biosimilar and biologics.

Biosimilar innovative products are on the rise. The number of new drugs seeking approvals are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of biomilars are expected to be in the market in 2016 compared to in the last 5 years.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany.

Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP),  Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Tack 13: BCS and IVIVC Based Biowaivers

The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and invitro and invivo classification discusses about ADME pathways of different drugs. This also includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro preclinical ADME/BCS testing.

Until in vitro in vivo correlation achieves the required degree, the biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy.

Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany.

Related Societies:

Societies in USA: American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP),  Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC).

Societies in Europe: Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS).

Societies in Asia and Pacific: Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS).

Track 14: Biosimilar Market & Cost Analysis

This track is concentrated towards the different reviews and forecasts regarding the scnario of Biosimilars market and follow on Biologics. The present status and future scenario of the market are best to be discussed during this session. Market researches from the first launching of biosimilar to the newest one till date prospects for a radical change in the pharmaceutical market. Market researchers, market analysts, industrialists would be the apt participants for this session at Euro Biosimilars 2017.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy.

Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany.

Related Societies:

Societies in USA: American Society of Health-System Pharmacists (ASHYP),  Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT).

Societies in Europe: Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF).

Societies in Asia and Pacific: Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA).

Track 15:  Challenges in Biosimilars Pharmacovigilance

This session of the European Biosimilars Congress 2016  looks into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.


Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 16: Legal Issues and BPCI Act

The legal issues pertaining to the the follow-on-biologics and biosimilars are one of the most aspects that requires an open discussion. Before the actual advent of biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law.

By 2002, the FDA had approved 36 new biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK.

5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Track 17: Biologic Drugs

Biologic Drugs, or biologic response modifiers, are medications genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. Biologics target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. Biologic response modifiers (biologics for short) are drugs that are genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. They target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. The proteins targeted include tumor necrosis factor (TNF), interleukin-1 (IL-1) and interleukin-6 (IL-6), which are involved in joint inflammation. Biologics are typically reserved for people whose arthritis has not responded well to disease-modifying antirheumatic drugs (DMARDs).

Related Conferences: Biosmilar Events | Biosimilar Conferences | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conferences, April 09-11 2018, Amsterdam, Netherlands; 13th European Pharma Conferences May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conferences, June 11-13, 2018 at Rome, Italy; 4th Conference on Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conferences, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Congress 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; World Congress of Pharmacy and Pharmaceutical Sciences September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT).

Societies in Europe: Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF).

Societies in Asia and Pacific: Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA).

Track 18: Biological Medicine

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Dis-ease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease- the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands;13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK; Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany.

Related Societies:

Societies in USA: American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC).

Societies in Europe: Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS).

Societies in Asia and Pacific: Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS).

Track 19: Biowaiver

A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. At that time the Biowaiver was only considered for scale-up and post approval changes (SUPAC) to pharmaceutical products.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Canadian Society for Pharmaceutical Sciences (CSPS), Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP).

Societies in Europe: Belgian Society of Pharmaceutical Sciences (BGFW), European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI).

Societies in Asia and Pacific: The Pharmaceutical Society of Australia (PSA), Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA).

Track 20: Biobetters

The term biobetter refers to a recombinant protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters build on the success of existing, approved biologics but are considered less of a commercial risk than developing a brand new class of biologic. Biobetters are not entirely new drugs and they aren't generic versions of drugs, either. While many consider biosimilars to be generic versions of biotech drugs, it isn't possible to create a generic biologic drug. That's because biopharmaceuticals are produced in living organisms - such as animals or bacteria - and cannot be copied exactly.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands; 13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK;10th Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain;8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany.

Pharmaceutical Technology Meeting, March 19-22, 2018 at Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018 at London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin, Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

Track 21Entrepreneurs Investment Meet

Entrepreneurs who are willing to put in hard work and invest in the field of biologics and biosimilars will find this meeting the best place to properly shape their drive for the new endeavours. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile. The best technological knowhow, economical aspects, regulatory red tapes and profit shares involving biosimilars and biologics shall be discussed at this Euro Biosimilars Global Event.

Related Conferences:  Biosimilar Conferences | Biosmilar Events | Biosimilar Workshops | Biosimilar Symposiums | Biosimilar Meetings

13th European Pharma Conference May 07-09, 2018 at Frankfurt, Germany; 4th Marine Drugs and Natural Products Conference, June 11-13, 2018 at Rome, Italy; 4th Antibiotics Conference; June 14-15, 2018, Barcelona, Spain; 9th Pharmacovigilance Exhibition, June 21-22, 2018 at London, UK; Pharmacology Conference, Jul 30-Aug 01, 2018 at Barcelona, Spain; 8th Environmental Chemistry Conference, September 20-22, 2018 Berlin, Germany; 14th Nanomedicine and Pharmaceutical Nanotechnology Conference, April 09-11 2018, Amsterdam, Netherlands.

Pharmaceutical Technology Meeting, March 19-22, 2018, Granada, Spain; 5th Biosimilars and Biobetters Conference 16 - 17 April 2018, London, UK; Conference on Supply Chain Security and Management October 24-26, 2018 Berlin Germany; Pharmacy and Pharmaceutical Sciences Conference; September 02-06, 2018, Glasgow, UK.

Related Societies:

Societies in USA: Pharmaceutical Manufacturers Association of Canada (PMAC), American Association of Pharmacy Technicians (AAPT), American Society of Health-System Pharmacists (ASHYP), Canadian Society for Pharmaceutical Sciences (CSPS).

Societies in Europe: European Federation for Pharmaceutical Sciences (EUFEPS), Italian Society for Pharmaceutical Sciences (SISF), Association of the British Pharmaceutical Industry (ABPI), Belgian Society of Pharmaceutical Sciences (BGFW).

Societies in Asia and Pacific: Austrian Pharmaceutical Society (APS), Korean Research-based Pharmaceutical Industry Association (KRPIA), Kuwait Pharmaceutical Association (KPA), The Pharmaceutical Society of Australia (PSA).

About Conference


With 10 years now added to its repertoire, European Biosimilars Congress is really turning into a staple meeting where biosimilar partners accumulate to address the present and future condition of Biosimilars in the Europe.

The expansion of two devoted streams for the European Biosimilars Congress meeting was a hit – we could pick up knowledge from two particular group – one that exceeded expectations in the systematic and assembling end – and one that exceeded expectations in the business and key end.

The 2018 establishment of this meeting will enable us to keep on diving further into both the investigation of Biosimilar improvement – and the business requirements for organizations that keep on seeking FDA endorsement.

The Organizing Committee  is delighted to invite you to attend the 11th European Biosimilars Congress  one of its remarkable Pharmaceutical conferences, to be held during April 26-27, 2018 in RomeItaly. European Biosimilars Congress is a global annual event. This European Biosimilars Congress 2018 will bring together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world.Many biologics products are making their entry in the pharma market and experiencing a notable rise in their usage over the conventional medications.

At Euro Biosimilars 2018 meet your target audiences from around the world focused on learning about biologics and biosimilars. This conference would be your single best opportunity to reach the largest assemblage of participants from the biologics and biosimilars community.

2018 Highlights:

  • 300+ Participation (70 Industry: 30 Academia)
  • 10+ Keynote Speakers
  • 50+ Plenary Speakers
  • 20+ Exhibitors
  • 14 Innovative Educational Sessions
  • 5+ Workshops
  • B2B Meetings

Motives to attend:

  • Keynote presentation along with interactions to galvanize the scientific community.
  • Workshop and symposiums to reach the largest assemblage of participants from the  Pharma/Biotech community.
  • A wide track of exhibitors to showcase the new and emerging technologies.
  • Platform to global investment community to connect with stakeholders in Pharma/Biotech sector.
  • Young Scientist/ Investigators Award geared towards best budding young research.
  • Links to the political marketing resources  in order to expand your business and research network.
  • Triumph of Awards, Certificates recognizes your commitment to your profession to encourage the nascent research.

Euro Biosimilars 2018 has everything you need:

Open panel discussions: Providing an open forum with experts from academia and business to discuss on current challenges in Biosimilars & Biologics, where all attendees can interact with the panel followed by a Q&A session.

Speaker and poster presentations: Providing a platform to all academicians and industry professionals to share their research thoughts and findings through a speech or a poster presentation.

Editorial board meeting: Discussing on growth and development of open access Bioanalysis & Biomedicine International Journals and recruiting board members and reviewers who can support the journal.

Round table meetings: Providing a platform where industry professionals meet academic experts.

Over 50+ organizations and international pavilions will be exhibiting at the Euro Biosimilars 2018  conference. . Exhibitors will include equipment manufacturers and suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies.

In addition to the products and services you will will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.

The Euro Biosimilars 2018  has everything you need, all under one roof, saving you both time and money.   It is the event you cannot afford to miss!

Target Audience:

  • Directors, CEO’s of Organizations
  • Business Development Managers
  • Chief Scientific Officers
  • R&D Researchers from Biosimilar and Bioslogics Industries
  • Professors, Associate Professors, Assistant Professors
  • PhD Scholars
  • Patent Attorneys
  • Intellectual Property Attorneys
  • Investment Analysts
  • Association, Association presidents and professionals
  • Noble laureates in Health Care and Medicine
  • Bio instruments Professionals
  • Bio-informatics Professionals
  • Software development companies
  • Research Institutes and members
  • Supply Chain companies
  • Manufacturing Companies
  • CRO and DATA management Companies
  • Training Institutes
  • Business Entrepreneurs

Past Attendees Share Based on Professional Sectors:

 

 

Market Analysis

Biosimilars: Global Markets

As per market researchers the global biosimilars market was valued at $1.8 billion in 2013 and nearly $2.0 billion in 2014. The market is expected to reach nearly $4.0 billion by 2019, with a compound annual growth rate (CAGR) of 15% from 2014 through 2019.

The erythropoietins market segment saw revenue of $438.4 million in 2013 and $501.6 million in 2014. Revenue should reach nearly $1.2 billion by 2019, rising at a CAGR of 18.5% from 2014 to 2019.

Granulocyte colony-stimulating factors (G-CSFs) reached $379.3 million in 2013. This segment is expected to increase from $453.6 million in 2014 to $1.1 billion by 2019, a CAGR of 20.2% from 2014 to 2019.

Source: BCC Research

Importance & Scope:

The European-based pharmaceutical industry makes a major contribution to the Europe, not just in financial terms but also in terms of high-trait employment. Globally Pharma Market ranges from $870-$900 billion and in Europe $260-$280 billion.

A global biosimilars strategy:

Developed markets: Developed markets, with the exception of the United States, represent the greatest biosimilars presence today. Most biosimilars manufacturers have been and remain focused on the developed markets – whether it is for their historic and current opportunities (EU) or for their future market potential (United States, Japan). Dedicated regulatory pathways set the foundation for stringent, abbreviated approval processes which, in turn, have fed investor enthusiasm. Biosimilars adoption in developed markets has been primarily payer-driven, especially in European markets, given payers’ urgent, unmet need to contain public health care expenditures. Further market uptake has been slowed by prescribers’ skepticism and low patient awareness. Still, developed markets continue to have the highest number of biosimilars molecules in development – estimated at 29 in Europe, 19 in the United States and seven in Japan.

Emerging markets: In today’s emerging markets, biosimilars are still nascent, with little to no presence. However, in contrasting emerging markets with developed markets, the limited patient access to affordable biologics and the openness of physicians to low-cost therapies may offer potentially significant opportunities. Today, emerging markets represent a snippet of total world biologic sales in value, less than seven to eight percent (versus 48.6 percent in the United States).ix Treatment rates for flagship biologics are still low compared to developed markets, despite existing demand. For example, the treatment rate of MabThera® in Brazil is three times lower than in the UK and six times lower than in the US.x Additionally, a recent Kantor Health Survey found that 20 percent of emerging market autoimmune patients use a biologic, with the distribution of biologics varying from 29 percent in China to 12 percent in Russia and a mere 6 percent in Brazil.xi This may indicate the presence of large pockets of non-consumption, especially within the growing middle class.

Biosimilars Market Projected To Reach $41.7 Billion By 2024

Biosimilars Market, by Product (Revenue, USD Million, 2017 - 2024)

  • Recombinant Non-Glycosylated Proteins
    • Insulin
    • Human Growth Hormones
    • Granulocyte Colony-stimulating Factor (G-CSF)
    • Interferons
  • Recombinant Glycosylated Proteins
    • Erythropoietin
    • Monoclonal Antibodies
    • Follitropin

Biosimilars Market, by Application (Revenue, USD Million, 2017 - 2024)

  • Oncology
  • Blood Disorders
  • Growth Hormone Deficiency
  • Chronic and Autoimmune Disorders
  • Others

Biosimilars Market, by Region (Revenue, USD Million, 2017 - 2024)

  • North America
    • U.S.
    • Canada
  • Europe
    • UK
    • Germany
  • Asia Pacific
    • China
    • India
  • Rest of the World
    • Brazil
    • Russia

Analysis of selected countries:

 United States

  • FDA approval of the first biosimilar in March 2015 with Sandoz’s Zarxio (filgrastim)
  • About 19 pipeline biosimilar molecules in development
  • Represents about 50% of the global biologics market value and generates about 50% of the sales value growth
  • Pending legislative decisions on data exclusivity period, naming conventions and interchangeability likely to have important implications.

Biosimilars approved in the US

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product.

FDA is still in the process of developing guidelines regarding these types of products and has issued several guidance documents on the subject.

Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015. To date, FDA has approved four biosimilars within the product classes of anti-tumour necrosis factor-alpha (TNF-α) and granulocyte colony-stimulating factor, and a follow-on biological in the product class of insulin for use in the US.

FDA approved Biosimilars and follow-on Biologicals

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/ Company name

Amjevita (adalimumab-atto)

adalimumab

Ankylosing spondylitis
Crohn’s disease
Juvenile arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

23 Sep 2016

Amgen

Basaglar#

insulin glargine

Diabetes

16 Dec 2015

Eli Lilly/Boehringer Ingelheim

Epoetin Hospira

epoetin alfa

Anaemia (chronic kidney disease, Zidovudine, chemotherapy)
Reduction of allogeneic red blood cell transfusions

Recommended for approval by FDA’s Oncologic Drugs Advisory Committee (ODAC) on 25 May 2017

Pfizer (Hospira)

Erelzi (etanercept-szzs)

etanercept

Axial spondyloarthritis
Polyarticular juvenile idiopathic arthritis
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis

30 Aug 2016

Sandoz

Inflectra
(infliximab- dyyb)

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

5 Apr 2016

Pfizer (Hospira)

Renflexis (infliximab-abda)

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

21 Apr 2017

Samsung Bioepis

Zarxio
(filgrastim-sndz)

filgrastim

Autologous peripheral blood progenitor cell collection and therapy 
Bone marrow transplantation 
Cancer 
Myeloid leukaemia 
Neutropenia

6 Mar 2015

Sandoz

*Data collected on 30 September 2016, updated 26 June 2017

Source: US FDA

EU5

  • Most mature biosimilar market representing 80% of global biosimilar spending
  • Performance to date viewed as “disappointing” by select manufacturers
  • Nineteen biosimilar products authorized in four molecule classes: human growth hormone, erythropoietin, G-CSF and tumour necrosis factor (TNF)-inhibitor
  • About 29 pipeline biosimilars molecules in development.
  • World-class dedicated pathway leaving questions of substitutability at the pharmacy level to member states
  • Payer-driven uptake
  • Challenged by continued pressure from strict regulatory decisions, lingering fear from prescribers around biosimilars’ “similarity”, safety and efficacy, debates on automatic substitution and INN prescription.

Biosimilars approved in Europe

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then EMA has developed many general and specific guidelines for biosimilars .

Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006. To date, EMA has approved 38 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoesis stimulating agent, insulin, follicle-stimulating hormone (FSH), parathyroid hormone and tumour necrosis factor (TNF)-inhibitor, for use in the EU. Three biosimilar approvals have been withdrawn; two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and Biograstim in December 2016, and one for a somatropin biosimilar (Valtropin) in May 2012. This leaves a total of 35 biosimilars approved for use in Europe.

EMA approved Biosimilars:

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/Company name

Abasaglar (previously Abasria)

insulin
glargine

Diabetes

9 Sep 2014

Eli Lilly/Boehringer
Ingelheim

Abseamed

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

28 Aug 2007

Medice Arzneimittel Pütter

Accofil

filgrastim

Neutropenia

18 Sep 2014

Accord Healthcare

Amgevita

adalimumab

Crohn’s disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Spondylarthritis
Suppurativa hidradenitis
Ulcerative colitis
Uveitis

22 Mar 2017 

Amgen

Benepali

etanercept

Axial spondyloarthritis
Psoriatic arthritis
Plaque psoriasis
Rheumatoid arthritis 

14 Jan 2016

Samsung Bioepis

Bemfola

follitropin alfa

Anovulation (IVF)

24 March 2014

Finox Biotech

Binocrit

epoetin alfa

Anaemia
Chronic kidney failure

28 Aug 2007

Sandoz

Biograstim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008 
Withdrawn on 22 Dec 2016

CT Arzneimittel

Blitzima

rituximab

Non-Hodgkin lymphoma
Chronic B-cell lymphocytic leukaemia

CHMP positive opinion on 18 May 2017

Celltrion

Epoetin alfa Hexal

epoetin alfa

Anaemia
Cancer
Chronic kidney failure

28 Aug 2007

Hexal

Erelzi

etanercept

Ankylosing spondylitis
Juvenile rheumatoid arthritis
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis

CHMP positive opinion on 21 April 2017

Sandoz

Filgrastim Hexal

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

6 Feb 2009

Hexal

Filgrastim ratiopharm

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008
Withdrawn on 20 Apr 2011 

Ratiopharm

Flixabi

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

26 May 2016

Samsung Bioepis

Grastofil

filgrastim

Neutropenia

18 Oct 2013

Apotex

Inflectra

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

10 Sep 2013

Hospira

Inhixa

enoxaparin sodium

Venous thromboembolism

15 Sep 2016

Techdow Europe

Insulin lispro Sanofi

Insulin lispro

Diabetes mellitus

CHMP positive opinion on 18 May 2017

Sanofi-Aventis

Lusduna

insulin glargine

Diabetes

4 Jan 2017

Merck (MSD)

Movymia

teriparatide

Osteoporosis

11 Jan 2017

STADA Arzneimittel

Nivestim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

8 Jun 2010

Hospira

Omnitrope

somatropin

Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome

12 Apr 2006

Sandoz

Ovaleap

follitropin alfa

Anovulation (IVF)

27 Sep 2013

Teva Pharma

Ratiograstim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

Ratiopharm

Remsima

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

10 Sep 2013

Celltrion

Retacrit

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

Hospira

Ritemvia

rituximab

Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma

CHMP positive opinion on 18 May 2017

Celltrion

Rixathon

rituximab

Chronic B-cell lymphocytic leukaemia
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis

CHMP positive opinion on 21 April 2017

Sandoz

Riximyo

rituximab

Chronic B-cell lymphocytic leukaemia
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Rheumatoid arthritis
Wegener granulomatosis

CHMP positive opinion on 21 April 2017

Sandoz

Silapo

epoetin zeta

Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure

18 Dec 2007

STADA R & D

Solymbic

adalimumab

Ankylosing spondylitis
Crohn’s disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Suppurativa hidradenitis
Ulcerative colitis

22 Mar 2017

Amgen

Terrosa

teriparatide

Osteoporosis

4 Jan 2017

Gedeon Richter

Tevagrastim

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

15 Sep 2008

Teva Generics

Thorinane

enoxaparin sodium

Venous thromboembolism

15 Sep 2016

Pharmathen

Truxima

rituximab

Chronic lymphocytic leukaemia
Granulomatosis with polyangiitis
Microscopic polyangiitis
Non-Hodgkin’s lymphoma
Rheumatoid arthritis

17 Feb 2017

Celltrion

Tuxella

rituximab

Wegener granulomatosis
Microscopic polyangiitis
Non-Hodgkin Lymphoma
Chronic B-cell lymphocytic leukaemia

CHMP positive opinion on 18 May 2017

Celltrion

Valtropin

somatropin

Pituitary dwarfism
Turner syndrome

24 Apr 2006
Withdrawn on 10 May 2012 

BioPartners

Zarzio

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

6 Feb 2009

Sandoz

*Data collected on 30 September 2016, updated 26 June 2017

Source: EMA

Japan

  • Limited maturity of the biosimilar market
  • Dedicated regulatory pathway
  • About seven pipeline biosimilar molecules in development
  • Growth potential considered limited today based on the reluctance from both prescribers and patients as well as the general mistrust toward “generic makers
  • A push from payers, which has yet to be seen, may help open up the market.

Brazil

  • Led the way with the development of biosimilars regulations in Latin America and released biosimilars guidance in 2010
  • Reducing the reliance on imported (and high-cost) medicines through policies that favor the expansion of the domestic pharmaceutical industry and public-private partnerships to expand access to drugs
  • International companies have entered the market through partnerships and acquisitions (e.g., Pfizer’s 40% stake in Teuto, Sanofi’s acquisition of Medley and Merck’s joint venture with Supera, co-owned by Cristalia and Eurofarma)
  • The regulatory environment and interest of domestic and international manufacturers are major drivers in expanding the biosimilars market.
  •  Approximately five biosimilar molecules in the development pipeline.
  • Seventy-five percent of physicians surveyed in Brazil considered rituximab difficult to access due to high costs and 77% said they would increase prescription of rituximab if a cheaper alternative were available.

Russia

  • Aims to boost its domestic pharmaceutical market and increase the market share of domestic players from 20% in 2012 to 50% by 2020
  • The strong preference for local manufacturers will require international companies to engage in cooperative partnerships with Russian companies
  • Indicative of the burgeoning domestic industry, a rituximab biosimilar, developed by Russian company Biocad, was the first mAb biosimilar approved in Russia in April 2014
  • About eight biosimilar molecules in the development pipeline.

India

  • Biosimilar guidelines established in 2012
  • 80% of pharmaceutical spend is out of pocket
  • Indian companies have extensive experience with generics and have made in-roads in other countries as well through exports
  • Indian companies grapple with the image of manufacturing as unsafe with poor quality drugs
  • Partnerships between global pharmaceutical companies and domestic companies are helping to improve the quality of biosimilars marketed in India
  • Approximately 19 biosimilars in the development pipeline; large proliferation of non-original biologics
  • Large middle class with growing disposable income who prefer brand name products, so there is a good opportunity for branded Biosimilars.

Approximately 70% of the country’s population is considered rural and will focus on the cost of therapy – a 20-30% discount on originator biologics may not be sufficient.

China
  • Issued draft biosimilars guidelines in 2014; once a clear regulatory pathway for biosimilar approval is established, the market will be very attractive – not only due to the volume potential but also the growing ability to pay
  • Similar to the tight controls requiring international companies to create partnerships or use domestic pharmaceutical distributors, the successful manufacturing and marketing of biosimilars will also require partnerships with domestic companies
  • Lack of physician trust and enthusiasm for non-branded drugs exacerbated by unsafe and counterfeit drugs
South Africa
  • Sophisticated market; generics make up more than 50% of the market
  • Biosimilars guidelines were established in 2010
  • There is a financial pressure on the system overall, and great pressure to utilize generics including biosimilars
  • Several Indian companies have entered the South African market and are key to keeping drug costs low
  • There is a cost containment focus from the government and payer side and a quality focus from the physician and patient side
  • Companies will have to bring in a cost structure that is lower than what currently exists along with the highest quality and safety profiles of their biosimilars
Mexico
  • Established, government-incentivized market for biosimilars
  • Demand spurred by high out-of-pocket health care spending (estimated at +90%)
  • Significant presence of non-original biologicals known as “biolimbos” who have not undergone marketing authorization review consistent with globally accepted standards.
  • Biosimilars development led locally by Probiomed which won six biosimilars approvals, including a version of Rituxan®
South Korea
  • Most mature biosimilar “development” market
  • Enabled by unprecedented support from the South Korean government: 35% of the national medical R&D budget was invested into biosimilars development in 2012xvi
  • Government-set goal for domestic biopharmaceutical companies to win 22% of the global biosimilars market by 2020
  • Twelve biosimilars have been approved and another 36 biosimilars are in the pipelinexvii
  • Leading the race in the high-risk and complex development of monoclonal antibody (mAb) biosimilars with 17 mAbs in the pipeline

A recent study revealed that a third of anti-malaria drugs sold were found to be counterfeit, and 100,000 deaths per year in Africa were linked to counterfeit drugs. Physicians and patients in emerging markets are particularly wary of non-brand name drugs. 75% of emerging markets pharmaceutical growth is expected to come from branded generics. According to a 2013 Roper Report, 79 percent of consumers in developing Asian markets and 61 percent of consumers in Latin American markets only buy products and services from a trusted brand.

Main factors that support a sustainable european biosimilar drugs market:

A study conducted by the consultancy company GFK on behalf of the European Biosimilars Group It analysed the main factors that support a sustainable European biosimilar drugs market. The study revealed that biosimilar medicines provide a major opportunity with considerable benefits, since they lead to cost savings throughout Europe, contribute to the sustainability of National Healthcare Systems and improve patient access to innovative treatments. However, in order to achieve these benefits in the long term, the biosimilar medicines market must continue to be sustainable.

The study concluded that the main factor influencing the sustainability of the biosimilar medicines market and enabling biosimilar drug implementation is that this market must be attractive and deliver continuing benefits, in both the short and long term, to the four key stakeholder groups: physicians, payers, patients and industry. However, the study emphasises that the “attractiveness” and “benefit” concepts are different in each of these groups. In this way, for physicians it involves having more opportunities to treat more patients with appropriate therapies. For payers, it entails cost savings and the financial sustainability of healthcare systems. For patients, it means having improved access to medicines. Finally, for the industry, it involves a reasonable return on investment with the continued attractiveness of R&D investment in new medicines development.

On the other hand, other factors that strongly influence the development and implementation of biosimilars include the prescribing physician’s trust, the complexity of clinical development and the uncertain regulatory framework. In order to increase the prescribing physicians’ trust, they must have a good understanding of biosimilars. In fact, as we already stated in a previous post, the consultancy company PwC (PricewaterhouseCoopers) revealed that only 17% of survey respondents chose the correct biosimilar definition from a list provided (PwC Health Research Institute, Top Issues Consumer Survey, 2015). Therefore, a series of training programs have been established providing clear information about them, including courses, discussion forums, conferences and newsletters. The complexity of clinical development is another important factor because it has a direct impact on obtaining marketing authorisation approval from regulatory authorities, such as the Food and Drug Administration (FDA) in the Unites States, and the European Medicines Agency (EMA) in Europe. The more complex a drug’s clinical development is, the more time is required to obtain the marketing authorisation and the longer it takes to implement it. Finally, the legal framework regulating the development, approval, marketing and implementation of biosimilars, depending on the country, is quite uncertain and vague. However, it is true that Europe has been pioneering in the establishment of a legal framework and guidelines for the approval of biosimilars. In fact, the Spanish Ministry of Health, Social Services and Equality published the Price Referencing Order (SSI/1305/2016) in Spain’s Official State Gazette (BOE) which marks the introduction of biosimilars into the health system.

Critical Analysis:

The capital-intensive nature of the biosimilar business and long gestation periods between initial investment and commercialization require biosimilar players to take a higher level of risk than their counterparts in the smallmolecule generics business, and this can be a significant barrier to entry for many start-ups.

Major Biosimilars Associations in Europe

 

 

Past Conference Report

Biosimilars-euro 2017

Conference Series hosted the 7th  European Biosimilars Congress at Novotel München City Arnulfpark Munich, Germany during May 15-16, 2017.The conference was designed around the theme of “The developmental strategies and uptake of biosimilars through a decade in Europe” and was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering. Moreover, the networking sessions laid the foundation for some time worthy collaborations between many start-up and big industries. The post conference networking lunch session witnessed a number of B2B meetings that are turning up to be mutually beneficial to both the organizations who had gone in for the business meetings.

Euro Biosimilars 2017 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Biologics and Biosimilars. This congress not only brought forward the latest developments in the field but also provided solutions to the numerous challenges encountered in developing a biosimilar.

Conference Series would like to convey a warm gratitude to all the Honorable guests, Keynote Speakers, Delegates, Media Partners and Exhibitors for their participation in Euro Biosimilars 2017.

Christoph Volpers, Michalski & Hüttermann, Germany

Arthur G Cook, ZS Associates, USA

Tim Demuth, Sandoz Pharmaceuticals GmbH, Germany

Rosa Helena Bustos, University of La Sabana, Colombia

Ulrike Konrad, Protagen Protein Services , Germany

Stanley Seung Suh Hong, Celltrion Healthcare Co. Ltd., South Korea

Ulrich Storz, Michalski Hüttermann & Partner, Germany

We on behalf of the conference specially thank the exhibitors for their participation in the congress and  also the media partners for their wonderful marketing of the event. Conference Series also took the privilege of felicitating Euro Biosimilars 2017 Organizing Committee, Keynote Speakers and Chair whose support made conference a great success.

With the enormous feedback from the participants and supporters of Euro Biosimilars 2017, we are glad to announce 11th European Biosimilars Congress during April 26-27, 2018 Rome, Italy.

 


Past Reports  Proceedings  Gallery  

Euro Biosimilars 2016

Conference Series LLC hosted the 5th European Biosimilars Congress at Hotel Meliá Valencia in Valencia, Spain during June 27-29, 2016.The conference was designed around the theme of “The European perspective of Biologics and Biosimilars” and was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering. Moreover, the networking sessions laid the foundation for some time worthy collaborations between many start-up and big industries. The post conference networking lunch session witnessed a number of B2B meetings that are turning up to be mutually beneficial to both the organizations who had gone in for the business meetings.

Euro Biosimilars 2016 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Biologics and Biosimilars. This congress not only brought forward the latest developments in the field but also provided solutions to the numerous challenges encountered in developing a biosimilar.

Conference Series LLC would like to convey a warm gratitude to all the Honorable guests, Keynote Speakers, Delegates, Media Partners and Exhibitors for their participation in Euro Biosimilars 2016.

Laszlo Endrenyi, University of Toronto, Canada

Candida Fratazzi, BBCR Consulting, USA

Kamali Chance, Quintiles Inc., USA

Andreu Soldevila, Lean Biopro, Spain

Ruideger Janwkosky, Cinfa Biotech GmbH, Germany
 


We on behalf of the conference specially thank the exhibitors for their participation in the congress and  also the media partners for their wonderful marketing of the event. Conference Series LLC also took the privilege of felicitating Euro Biosimilars 2016 Organizing Committee, Keynote Speakers, Chair and Co-Chairs whose support made conference a great success.

With the enormous feedback from the participants and supporters of Euro Biosimilars 2016, we are glad to announce 7th European Biosimilars Congress during May 15-17, 2017 at Munich, Germany and also invite you to participate at our 6th International Conference and Exhibition on Biologics and Biosimilars through October 19-21, 2016 at Houston, TX, USA.

 


Past Reports  Proceedings  Gallery  

Biosimilars 2015

We hosted the 4th International Conference and Exhibition on Biologics and Biosimilars at Double Tree by Hilton Hotel Baltimore, USA during October 26-28, 2015.The conference was designed around the theme of “ The future of Next Generation Biologics and Biosimilars”  and was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering.

Biosimilars 2015 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Biologics and Biosimilars.

OMICS International would like to convey a warm gratitude to all the Honorable guests, Keynote Speakers, Media Partners, Exhibitors and Covance Laboratories as sponsors of Biosimilars 2015:

Patrick Lucy, Pfenex Inc., USA
Kamali Chance, Quintiles Inc., USA
Christopher Leintz, Pfizer, USA

Mark A Emalfarb,  Dyadic Internatrional, USA

Sarfaraz K NIazi, Therapeutic Proteins International, USA

Angela Furlanetto, Dimock Stratton LLP, Canada


On behalf of the conference, we congratulate the Best Poster awardees for their outstanding performance and appreciates all the participants who put their efforts in poster presentations and sincerely wishes them success in future endeavours. 

We had taken the privilege of felicitating Biosimilars 2015 Organizing Committee, Keynote Speakers, Chair and Co-Chairs whose support made conference a great success.

With the enormous feedback from the participants and supporters of Biosimilars 2015, OMICS International is glad to announce 5th European Biosimilars Congress during June 27-29, 2016 at Valencia, Spain and 6th International Conference and Exhibition on Biologics and Biosimilars through October 20-22, 2016 at Houston, USA


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To Collaborate Scientific Professionals around the World

Conference Date April 26-27, 2018

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Past Affiliations

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Keytopics

  • Biosimilar Product Development
  • Abbreviated Clinical Trial Designs
  • Analytical Strategies For Biosimilars
  • BCS Based Biowaivers
  • Bio Similar Innovative Devices
  • Bioequivalence Assessment
  • Biological Licenses
  • Biosimilar Companies
  • Biosimilar Cost Analysis
  • Biosimilar Manufacturer Strategies
  • Biosimilar Market
  • Biosimilar Medicines
  • Biosimilars And Biologics
  • Biosimilars And Their Social Repercussions
  • Biosimilars Approved In Europe
  • Biosimilars Approved In US
  • Biosimilars Economic Predictions
  • Biosimilars In Developing Countries
  • Biosimilars Manufacturing Process
  • Biosimilars Research Pipeline
  • Challenges In Biosimilars Pharmacovigilance
  • Clinical Development Of Biosimilars
  • Commercial Landscape In Biosimilars
  • Comparison Of Biologic Drug Prices
  • Consequences Of Brexit On Biosimilars
  • Current Challenges In Developing Biosimilars
  • Differences Between Biosimilars And Generic Drugs
  • Emerging Biosimilars In Therapeutics
  • Fingerprinting Analysis
  • Future Of Biosimilars
  • Globalization Of Biosimilars
  • Health Technology Assesment Of Biosimilars
  • Innovative Approach For Biosimilars
  • Intellectual Property Rights
  • Interchangeability Of Biosimilars
  • Investigator Initiated Biosimilar Research
  • IVIVC Based Biowaivers
  • Laws On Biologics Regulation
  • Legal Issues And BPCI Act
  • Market Analysis Of Biosimilars
  • Need For Biosimilars
  • New Pathway For Biosimilars
  • Outlook On Biosimilars
  • Patient Safety In Biosimilars
  • Quality Considerations For Biosimilars Biosimilars
  • Reimbursement And Coding In Biosimilars
  • Stability Of Biosimilars
  • Substitution Of Biosimilars
  • The Savings Potential Of Biosimilars
  • Therapeutic Efficiency Of Biosimilars
  • What Are MAbs Biosimilars?
  • What Is A Biologic Medicine?
  • What Is A Biosimilar Medicine?
  • Worldwide Regulatory Status Of Biosimilars