The development, manufacturing and commercialization of biosimilars has become a much more complex endeavor than originally anticipated by many companies. Regulatory expectations for biosimilars in terms of characterization, biosimilarity, comparability, clinical studies, biological assays and more have resulted in a renewed emphasis on developing efficient processes and strategies to accelerate development. This multi-speaker workshop will provide an overview of biosimilars, and may include presentations on best practices, case studies, regulatory perspectives and lessons learned from current biosimilar development programs.
Chairperson and Introduction:
David Wylie, Ph.D., Principal Scientist, Biologics Analytical Sciences, Merck and Co.
Strategies for a Successful Biosimilar Product Development
Sadettin Ozturk, SVP, Process and Analytical Development, MassBiologics, USA
The field of biosimilars or “follow-on biologics” is active, in an effort to make biologics more affordable and more accessible. Several products are already approved and there are many products in development around the globe. While developing, a biosimilar product seems to be easier and cheaper than the original product; demonstrating comparability, addressing regulatory issues, and uncertainties about the future, pose significant hurdles to companies hoping to bring biosimilars to market. Expertise in biological product development, ability to link process conditions to product attributes, strong analytical skills, and clear clinical and regulatory strategies are critical to the success of biosimilar product development. This talk will present challenges and opportunities in the field and provide strategies for successful development of biosimilars.
Analytical and Formulation Methods for Biosimilar and Interchangeable Development
Tudor Arvinte, Ph.D., Professor, University of Geneva, Switzerland & CEO of Therapeomic Inc.
The importance of orthogonal analytical methods in the characterization and formulation development development of biosimilar products will be documented by case studies. Examples will be presented of analytical approaches for the comparison of biosimilar and originator products regarding: i) the chemical and physical properties of the molecule and of the formulation ingredients; ii) batch-to-batch variation; and iii) potential aggregation of drug products after mixing with human plasma.
Biosimilars: the current state of the Biologics Price Competition and Innovation Act (BPCIA) and overview of the anti-patent climate
Joanna Brougher Esq., MPH, Owner & Principal at BioPharma Law Group PLLC
One June 12, 2017, the United States Supreme Court, in a unanimous opinion, reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting two “patent dance” provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). This decision permits manufacturers of biosimilars to begin marketing their biosimilar product prior to FDA approval and deprives the owner of the reference product of a means to force disclosure of the method used to manufacture the biosimilar. While the Supreme Court’s decision is largely seen as a victory for manufacturers of biosimilars who now have fewer obstacles to overcome in reaching the market, there are still many unanswered questions remaining following the decision. Some of the major topics that will be covered in this workshop are: an overview of the BPCIA, recent court decisions, who will “dance” now?, potential litigation strategies, and unanswered questions.
Group Discussion: Best Practices and Lessons Learned for Developing Biosimilars
Moderator: David Wylie, Ph.D., Principal Scientist, Biologics Analytical Sciences, Merck and Co.
Co-Moderator: Gay Gauvin, Global Operations Director, Biosimilars, Amgen
Monday, September 25:
Refreshment Break: 10:15-10:45
Refreshment Break: 2:45-3:15