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Learning Tracks

Outstanding Legal & Regulatory Issues for Biosimilars

Wednesday, November 10, 2021

12:00 p.m. - 1:00 p.m.

Companies are developing more biosimilars and FDA’s biosimilars regulatory review and oversight programs are maturing, leading to questions about how to solve regulatory challenges both new and familiar. For example, what has FDA learned now that Agency has approved an interchangeable product?  Can we expect new guidance or updated thinking with respect to the pathway to pharmacy substitutability? Other topics that raise questions include first interchangeable exclusivity, and labeling supplements for biosimilars.

Moderator: Rachel Turow, JD, MPH
Associate General Counsel, Regulatory Law & Policy Head, U.S. Regulatory Policy, Teva Pharmaceuticals

Alison Falb 
Regulatory Counsel, OTBB, OND, CDER, FDA

Eva Temkin, JD 
Partner, FDA and Life Sciences, King & Spalding LLP

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