×
Back to Agenda
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
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
FDA Update
Partner, Arnold & Porter, United States
Moderator
Senior Director, Global Regulatory Policy, MRL GRACS , Merck & Co., Inc., United States
Have an account?