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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Regulatory Barriers to Entry for Biosimilars

Session Chair(s)

Rachel  Turow, JD, MPH

Rachel Turow, JD, MPH

Managing Counsel, FDA Regulatory

Walmart, Inc., 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

Industry Update

Leah Christl, PhD

Amgen, United States

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

Eva  Temkin, JD

FDA Update

Eva Temkin, JD

King & Spalding LLP, United States

Partner, FDA and Life Sciences

Julie Anne  Zawisza, MA, MT

Moderator

Julie Anne Zawisza, MA, MT

Merck & Co., Inc., United States

Senior Director, Global Regulatory Policy, MRL GRACS

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