6^th International Conference and Exhibition on Biologics and Biosimilars Organizing Committee invites you to attend the largest assemblage of biologics and biosimilars researchers from around the globe during October 19-21, 2016 at Houston, TX, USA. 

Biosimilars 2016 is a global annual event. This Biosimilars Congress 2016 brings together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. The passage of approval for biosimilars Inflectra 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 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 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:

7^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit August 29-31, 2016 Atlanta, USA; 7^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials September  19-21, 2016 Vienna, Austria; 12^th Euro Global Summit on  Cancer Therapy September 26-28, 2016 London, UK; 5^th International Conference on Medicinal Chemistry and Computer Aided  Drug Designing December 01-03, 2016 Chicago, USA. BioSim-Asociación Española de Biosimilares , Medicines for Europe(EGA) , GPhA-Generic Pharmaceutical Association , IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association

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 Filgrastim, Pegfilgrastim, Recombinant blood products, therapeutic proteins, vaccines, Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments.

Related Conferences:

2^nd 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,  4^th 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, 6^th World Congress on Cancer Therapy December  01-03, 2016 Baltimore, USA. 17^TH World Conference On Lung Cancer  December 4 – 7, 2016,Vienna, Austria. IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares, Medicines for Europe(EGA), GPhA-Generic Pharmaceutical Association

Track 3: Biosimilars Analytical Strategies

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, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.

Related Conferences:

2^nd International Meeting on Clinical Case Reports  April 18-20, 2016 Dubai, UAE, 7^th World Congress on Bioavailability and Bioequivalence: BA/BE Studies Summit August 29-31, 2016 Atlanta, USA, 5^th Global Summit on Toxicology & Applied Pharmacology September 19-21, 2016 Las Vegas, USA, 6^th Euro-Global Summit on Toxicology & Applied Pharmacology October 27-29, 2016 Rome, Italy . BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares, GPhA-Generic Pharmaceutical Association, IGBA- International Generic and Biosimilars Medicines Association, Medicines for Europe(EGA)

Track 4: Regulatory Approach for 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. Biosimilars 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. 

Related Conferences:

8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Spain, 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, 2^nd 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 Valencia, Spain,  19^th International Conference on Pharmaceutical Regulatory Affairs  Doha,Qatar  November 9-10,2017. IGBA- International Generic and Biosimilars Medicines Association, Medicines for Europe(EGA), BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares

Track 5: Legal Issues and BPCI Act

 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:

Industrial Pharmacy April 28-29, 2016 Dubai, UAE, 6^th International  Conference and Exhibition on Biologics and Biosimilars October 19-21, 2016 Houston, TX, USA, Drug Formulation  June 06-08, 2016 Beijing ,China,2^nd International Conference and Expo on Parenterals & Injectables  December 05-07, 2016 Dallas, TX, USA. BioSim-Asociación Española de Biosimilares , Medicines for Europe(EGA) , GPhA-Generic Pharmaceutical Association , IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association

Track 6: 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 versions of original biosimilar innovator products, and can be manufactured when the original product's patent expires. This session shall be highly beneficial for the biosimilar industry researchers to update themselves on the latest research updates from around the world. This session also finds place for all the biosimilar exhibitions associated with the field of biosimilars and biologics.

Related Conferences:

Advances in HPLC and Chromatography Techniques March 17-18, 2016 London, UK, Asia Pacific Drug Formulation & Bioavailability Congress June 06-08, 2016 Beijing, China , 7^th International Conference and Exhibition on Analytical & Bioanalytical Techniques Sept 29-Oct 01, 2016 Miami, USA, 4^th International Summit on GMP, GCP & Quality Control October 26-28, 2015 Hyderabad, India. GPhA-Generic Pharmaceutical Association, BioSim-Asociación Española de Biosimilares, Medicines for Europe(EGA

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, LATAM 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:
 

8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Spain,  2^nd International Conference and Expo on Drug Discovery & Designing October 24-26, 2016 Istanbul, Turkey. BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares, GPhA-Generic Pharmaceutical Association, IGBA- International Generic and Biosimilars Medicines Association, Medicines for Europe(EGA)

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 Conferences:

2^nd International Conference on Clinical Trials, August 22-24, 2016 Philadelphia, USA; 5^th International Conference on Translational Medicine, November 17-19, 2016 San Francisco, USA; 7^th International Conference on Biomarkers and Clinical Research, November 28-30, 2016 Baltimore, USA; 4^th International Conference on Clinical Pharmacy, October 31-November 01, 2016 Las Vegas, USA; 6^th International Conference on Clinical and Experimental Cardiology, November 14-16, 2015 San Francisco, USA; 7^th International Conference on Pharmacovigilance and Clinical Trials, September 19-21, 2016 Vienna, Austria. BioSim-Asociación Española de Biosimilares, IGBA- International Generic and Biosimilars Medicines Association, Medicines for Europe(EGA), BGMA-British Biosimilars Association

Track 9: Intellectual Property Rights

Needless to mention differentially that any pharma product has to successfully pass through the regulatory affairs' scanners before being launched in the market. Biosimilars and biologics are no exceptions. Apart from regulatory aspects the companies developing these biosimilars and biologics tend to enjoy monopoly over their product. Intellectual Property Rights (IPR) and patents are ultimate tools to the biosimilar manufacturers for safeguarding their interests. Pharma  patent scenario, Criteria for patentability and patent claims, Patentable subject matter, biosimilar guidelines, biosimilar patent issues are key points of discussion in the segment. Patent analysts, law firms and legal authorities dealing with biosimilar regulatory affairs would find this conference a perfect platform to put forward their views on the topic.

Related Conferences:

8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems  March 07-09, 2016 Madrid, Spain, 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR September 12-14, 2016 San Atonio, USA, International Conference and Expo on Generic Drug Market  and Contract Manufacturing  Oct 31- Nov 02, 2016 Valencia, Spain,  19^th International Conference on Pharmaceutical Regulatory Affairs  Doha, Qatar  November 9-10,2017. Brazil Pharma Expo August 29-31, 2016 Sao Paulo, Brazil, 18th International Conference on Pharmaceutical Regulatory Affairs, August 8 - 9, 2016, Venice, Italy. IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares, Medicines for Europe(EGA), GPhA-Generic Pharmaceutical Association

Track 10: Bioequivalence Assessment

Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This also includes Strategies for the bioequivalence assessment of topical dosage forms, Bioequivalence assessment of respiratory dosage forms, Bioequivalence approaches for transdermal dosage forms.

Related Conferences:

Back to Basics in Pharmacovigilance  February 18-29, 2016 Whiteley, UK, Asia Pacific Mass Spectrometry  Congress  October 13-15, 2016 Kuala Lumpur, Malaysia, 2^nd International Conference on Therapeutic Drug Monitoring and Toxicogenomics  June 09-10, 2016 Dallas, USA. 5^th Global Summit on Toxicology & Applied Pharmacology  September 19-21, 2016 Las Vegas, USA. BioSim-Asociación Española de Biosimilares , Medicines for Europe(EGA) , GPhA-Generic Pharmaceutical Association , IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association

Track 11: BCS and IVIVC Based Biowaivers

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. 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. The  Biosimilars Congress 2016 aims at addressing all such challenges of the pharma formulation sector for biobetters, biologics, biosimilars and biowaivers.

Related Conferences:

6^th Medical Writing and Healthcare Communications Conference April 28-29, 2016 Dubai, UAE. 6^th International Conference and Exhibition on Biologics and Biosimilars October 19-21, 2016 Houston, USA. IGBA- International Generic and Biosimilars Medicines Association , BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares, Medicines for Europe(EGA), GPhA-Generic Pharmaceutical Association

Track 12: Biosimilar Companies and Market 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 Biosimilars 2016.

Track 13:  Challenges in Biosimilars Pharmacovigilance

This session of the Biosimilars 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:

2^nd International Conference on Therapeutic Drug Monitoring and Toxicogenomics June 09-10, 2016 Dallas, USA,  2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, USA, 5^th Global Summit on Toxicology & Applied Pharmacology  September 19-21, 2016 Las Vegas 4^th  International Conference on Clinical Pharmacy Oct 31 - Nov 01, 2016 Las Vegas, USA. IGBA- International Generic and Biosimilars Medicines Association, Medicines for Europe(EGA), BGMA-British Biosimilars Association, BioSim-Asociación Española de Biosimilares

Track 14: Brexit Effect on Biosimilars

The Brexit effect on Biosimilars tends to be negative. Not only would it be a major setback towards approval and launch of biosimilars to the market but also it would be hindrance towards the cost cutting approach taken up by NHS.With Britain being among principal clinical trial centers is owned to see a decrease in the willingness of the manufacturers and researchers to carry out any further trials in Britain. Also Brexit will cause the principal motive of Bristish Biosimilars Association(BBA) to fall back- which aimed at increasing the use of biosimilars

Track 15: Entrepreneurs 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 Biosimilars Global Event.

The Biosimilars conference 2016 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 Biosimilars 2016.

Touro College of Pharmacy organized a one day symposium cum pre-conference workshop on March 29, 2016 with a focus on “Advances in Generic Pharmaceuticals and Biosimilars”. The symposium was held at the Manhattan Campus of the Touro College of Pharmacy located at 231 West 124^th Street. Leading scientists in the pharmaceutical and biotechnology industry as well as in academia were present seminars addressing advances in the development, manufacturing, marketing and regulatory pathways of generics and biosimilars. The symposium was sponsored by ConferenceSeries Ltd.

The keynote speeches of the renowned industry professionals and academicians was a real value addition to all the attendees. It was a perfect platform for exchange of scientific knowledge between the industry and academic sector. A well organized pre conference workshop was conducted and we look forward towards the attendees to attend the Biosimilars 2016 conference in Houston, TX, USA during October 19-21, 2016.