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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)
Industry Update
Leah Christl, PHD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
FDA Update
Eva Temkin, JD
Arnold & Porter, United States
Partner
Moderator
Julie Anne Zawisza, MA, MT
Merck & Co., Inc., United States
Senior Director, Global Regulatory Policy, MRL GRACS