Theme: The developmental strategies and uptake of biosimilars through a decade in Europe

Euro Biosimilars 2017

Renowned Speakers

Euro Biosimilars 2017

Session/Tracks

7th European Biosimilars Congress 2017 Organizing Committee invites you to attend the largest assemblage of biologics and biosimilars researchers from around the globe during May 15-17, 2017 at Munich, Germany. 

European Biosimilars Congress is a global annual event. This European Biosimilars Congress 2017 will bring together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. The passage of biosimilars through a decade at Europe finds much requirement for discussion also focussing the latest developments in the field of biologics and biosimilars. A comprehensive approach for the discussion has been taken up as listed below under several tracks and sub-tracks below:

Track 1: Current Challenges of Biologics

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 Biosmilar Events| Biosimilar Conferences:
7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit August 29-31, 2016 Atlanta, USA; 7th International Conference and Exhibition on Pharmacovigilance & Clinical Trials September  19-21, 2016 Vienna, Austria; 12th Euro Global Summit on  Cancer Therapy September 26-28, 2016 London, UK; 7th International Conference on Medicinal Chemistry and Computer Aided  Drug Designing December 01-03, 2016 Chicago, USA. 

BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

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 Biologics Conferences| Biologics Meetings:
2nd International Conference and Exhibition on Pain Medicine  May 16-18, 2016 San Antonio, USA ,   Global Summit on Melanoma and Carcinoma July 14-15, 2016 Brisbane, Australia,  4th Global Experts Meeting  Neuropharmacology September 15-17, 2016 San Antonio, USA, 2nd World Congress and Expo. on Medical  Devices  December 01-03, 2016 Baltimore USA, 6th World Congress on Cancer Therapy December  01-03, 2016 Baltimore, USA. 17TH World Conference On Lung Cancer  December 4 – 7, 2016,Vienna, Austria.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry | Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines

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. Biosimilars analytical 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 Biosimilar Conferences| Biologics Workshops:
2nd International Meeting on Clinical Case Reports  April 18-20, 2016 Dubai, UAE, 7th World Congress on Bioavailability and Bioequivalence: BA/BE Studies Summit August 29-31, 2016 Atlanta, USA, 7th Global Summit on Toxicology & Applied Pharmacology September 19-21, 2016 Las Vegas, USA, 6th Euro-Global Summit on Toxicology & Applied Pharmacology October 27-29, 2016 Rome, Italy . 

Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 4: Regulatory Approach and Legal Issues 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 2016 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 Biologics Meetings| Biosimilars Conferences:

8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Germany, 18th International Conference on Pharmaceutical Regulatory Affairs Venice, Italy  August 8 - 9, 2016, Brazil Pharma Expo August 29-31, 2016 Sao Paulo, Brazil, 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR September 12-14, 2016 San Antonio, USA, 2nd Annual Congress on Pharma Middle East  October 12-14, 2016, International Conference and Expo on Generic Drug Market and Contract Manufacturing  Oct 31- Nov 02, 2016 Munich, Germany,  19th International Conference on Pharmaceutical Regulatory Affairs  Doha,Qatar  November 9-10,2017.

Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe | Pro Generika| The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association

Track 5: 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 Biosimilars Meeting| Biologics Symposiums:
Advances in HPLC and Chromatography Techniques March 17-18, 2016 London, UK, Asia Pacific Drug Formulation & Bioavailability Congress June 06-08, 2016 Beijing, China , 7th International Conference and Exhibition on Analytical & Bioanalytical Techniques Sept 29-Oct 01, 2016 Miami, USA, 4th International Summit on GMP, GCP & Quality Control October 26-28, 2015 Hyderabad, India.

German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry |BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | The Alliance for Safe Biologic Medicines

Track 6: 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 Biosimilar Conferences| Biologics Conferences:
8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Germany,  2nd International Conference and Expo on Drug Discovery & Designing October 24-26, 2016 Istanbul, Turkey.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

 Track 7: 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 Biosimilar Conferences| Biologics Conferences:
8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Germany,  2nd International Conference and Expo on Drug Discovery & Designing October 24-26, 2016 Istanbul, Turkey.

BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 8: 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. 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 Biosimilar Events| Biosimilars Conference:

2nd International Conference on Clinical Trials, August 22-24, 2016 Philadelphia, USA;7th International Conference on Translational Medicine, November 17-19, 2016 San Francisco, USA; 7th International Conference on Biomarkers and Clinical Research, November 28-30, 2016 Baltimore, USA; 4th International Conference on Clinical Pharmacy, October 31-November 01, 2016 Las Vegas, USA;6th International Conference on Clinical and Experimental Cardiology, November 14-16, 2015 San Francisco, USA; 7th International Conference on Pharmacovigilance and Clinical Trials, September 19-21, 2016 Vienna, Austria.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry | Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines

Track 9: Biosimilar Market & Cost Analysis

This track is concentrated towards the different reviews and forecasts regarding the scenario 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.

Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 10:  Pharmacovigilance on Biosimilars

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 Biosimilar Conferences| Biologics Meetings:

2nd International Conference on Therapeutic Drug Monitoring and Toxicogenomics June 09-10, 2016 Dallas, USA,  2nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, USA, 7th Global Summit on Toxicology & Applied Pharmacology  September 19-21, 2016 Las Vegas 4th  International Conference on Clinical Pharmacy Oct 31 - Nov 01, 2016 Las Vegas, USA.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

Track 11Entrepreneurs 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.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

The Euro Biosimilars conference 2017 is owned to bring together the worldwide top pharmaceuticals, biotechnology and regulatory representatives under one roof that will provide them the best platform to update and share knowledge related to biosimilars and biologics. Hence, the International Biosimilar Conference will unfold the multiple facets of biosimilars, ranging from the evolving regulatory landscapes, biosimilar guidelines to the legal and economic aspects and the then current challenges in biosimilar development. This biosimilar conference will focus on a variety of aspects of biosimilar product development to successful delivery of safe, efficacious and potent biosimilar products to the market. By attending this biologics conference one will gain a comprehensive outlook on the key issues surrounding biosimilars. An important platform for Biosimilars stakeholders to discuss and share best practices in expediting development in the field of Biologics and Biosimilars is ought to be Euro Biosimilars 2017.





About Conference

The Organizing Committee  is delighted to invite you to attend the 7th European Biosimilars Congress  one of its remarkable Pharmaceutical conferences, to be held during May 15-17, 2017 in Munich, Germany. European Biosimilars Congress 2016 brings together scientists, researchers and CROs from around the world. With the approval of second biosimilar by the USFDA-Inflectra the biosimilars market is owned to experience a exponential growth over the coming few years. 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 2017 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.

Why to attend???

Conduct demonstrations, distribute information, meet with current and potential Scientists to update yourself with latest technological advancememts and new research, and receive name recognition at this 3-days' event. World-renowned speakers, the most recent techniques, tactics, and the newest updates in the era of follow-on-biologics and biosimilars are hallmarks of this conference.

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

As per market researchers, the global biosimilar market is expected to be worth $24 billion in 2019-at compound annual growth rate (CAGR) of some 65% from 2014.Clinical trials at global level would incur an approximate cost of few hundred crores.The estimated cost of developing biosimilars for global markets is $75-250 million, while developing traditional non-biologic generics costs about $2-3 million. With the introduction of Inflectra on April 06, 2016 the Biosimilar Market will grow at even higher rate.

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.

Growth Potential of Biologics and Biosimilars Market in Germany

Potential factors to affect biosimilars market penetration:

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.

Major Biosimilars Associations in Europe





Past Conference Report

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  Gallery  



Past Conference Report

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


Past Reports  Gallery  



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Euro Biosimilars 2016
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