Learning Tracks

Post-Approval Changes for Biosimilars

Monday, October 2, 2023

11:15 a.m. - 12:15 p.m.

As more and more biosimilars are approved and marketed in the US the number of post-marketing changes and submissions to the FDA continue to increase. This leads to increased work for industry and the FDA assessment staff. This session will gather industry and FDA experts to discuss best practices for post-approval changes for biosimilars and how FDA and industry can work together to streamline this process for both stakeholders.


Candace Gomez-Broughton, PhD
Branch Chief, Division of Biotechnology Manufacturing, OPMA, OPQ, CDER, FDA

Maria Gutierrez-Lugo, PhD
Review Chief, Division of Biotechnology Review and Research III, OBP, OPQ, CDER, FDA

Samir Kumar Mandal, PhD
Senior Director, Regulatory Affairs, Dr.Reddy’s Laboratories Ltd.

John Pakulski, RPh
SVP Global Regulatory Affairs, Kashiv BioSciences, LLC


Emanuela Lacana, Ph.D.
Deputy Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA


Maria Burkholder, MHA
Senior Director, Regulatory Affairs, Biosimilars, Teva Pharmaceuticals