Learning Tracks

BsUFA III: What’s New, What Will it Mean for Industry and FDA, and an Update on FDA’s Implementation Plan

Wednesday, November 9, 2022

11:00 a.m. - 12:30 p.m.

Looking to get up to speed on BsUFA III? This panel convenes representatives from FDA, AAM, and industry to discuss what’s new in BsUFA III, the agreement’s associated timelines, and key messages and content published in the commitment letter. This panel also will cover any UFA-related add-on policies that have occurred since the original agreement was reached between the FDA and industry in the summer of 2021.

Moderator: Giuseppe Randazzo
Vice President, Sciences and Regulatory Affairs, AAM

Hillel Cohen, PhD 
Executive Director, Scientific Affairs, Sandoz

Andrew Kish
Director, Office of Program and Strategic Analysis, CDER, FDA

Kimberly Maxfield, PhD
Pharmacologist and BsUFA Regulatory Science Lead, OTBB, OND, CDER, FDA

Cory Wohlbach 
Vice President Biosimilars, Teva Pharmaceuticals

Sarah Yim, M.D.
Director, OTBB, OND, CDER, FDA