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Thursday, June 18 • 5:00pm - 6:00pm
#552 OD: ON DEMAND - Regulatory Barriers to Entry for Biosimilars

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Component Type: Session
Level: Advanced

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 Objectives

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.

Chair

Rachel SW Turow, JD, MPH

Speaker

Industry Update
Leah Christl, PhD

FDA Update
Eva Temkin, JD

Moderator
Julie Anne Zawisza, MA



Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
avatar for Leah Christl

Leah Christl

Executive Director, Global Biosimilars Reg Affairs, Regulatory & R&D Policy, Amgen, United States
Dr. Christl is currently an Executive Director of Global Regulatory and R&D Policy at Amgen. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs in the U.S. FDA's Center for Drug Evaluation and Research and was... Read More →
ET

Eva Temkin

Acting Director of Policy, Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Eva Temkin is the Acting Director for Policy in CDER’s Office of Therapeutics and Biologics, overseeing regulatory policy related to biosimilar, interchangeable, and other therapeutic biologic products. Ms. Temkin is also the lead for FDA’s Biosimilar Action Plan, which outlines... Read More →
avatar for Julie Anne Zawisza

Julie Anne Zawisza

MRL GRACS – Director, Global Regulatory Policy, Merck & Co., Inc.
Ms. Zawisza leads regulatory policy for Merck’s oncology and biosimilars businesses. She is Chair of the Biosimilars Forum Regulatory Committee and active on PhRMA and BIO committees for biosimilars and other key FDA policy initiatives. She is a Board member of The Alliance for... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session