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ON DEMAND - Regulatory Barriers to Entry for Biosimilars
Session Chair(s)
Rachel Turow, JD, MPH
Of Counsel, FDA Regulatory , Skadden, United States
FDA is making important strides in reviewing and approving biosimilars. But, there are still some limitations to the program under BsUFA II that are interfering with biosimilar sponsors' ability to access the market.
Learning Objective : Discuss how the regulatory process for biosimilars is hindering their uptake in the marketplace; Describe how the FDA can improve the regulatory process for biosimilars to encourage and improve market uptake.
Speaker(s)
Leah Christl, PhD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Industry Update
Eva Temkin, LLM
Partner, Arnold & Porter, United States
FDA Update
Julie Anne Zawisza, MA, MT
Senior Director, Global Regulatory Policy, MRL GRACS , Merck & Co., Inc., United States
Moderator
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