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.
Regulatory Counsel, OTBB, OND, CDER, FDA
Eva Temkin, JD
Partner, FDA and Life Sciences, King & Spalding LLP
Rachel Turow, JD
Associate General Counsel, Regulatory Law & Policy Head, U.S. Regulatory Policy, Teva