Learning Tracks

Generic drugs and biosimilars are expected to be similar to, though not identical, to their RLDs and reference products. What does similarity mean in the context of a combination product, particularly with respect to different device presentations? What are the advantages and drawbacks of comparative use human factors studies in evaluating similarity? This session will provide an understanding of regulatory challenges in developing and assessing generic and biosimilar combination products, while also exploring how flexible FDA policy should be with respect to interchangeable biosimilars given the statutory definition of sameness and whether interchangeable biosimilars and ANDAs should have the same comparability standards.

Moderator: Scott Kuzner, PhD
Senior Director, Sciences and Regulatory Affairs, AAM

Speakers:
Eva Temkin, JD
Partner, King & Spalding, LLP

Maria Burkholder, MHA
Senior Director, Regulatory Affairs Global Biosimilars, Teva Pharmaceuticals

Monifa Vaughn-Cooke, PhD
Director of Human Factors Education and Outreach, MedStar National Center for Human Factors in Healthcare