Learning Tracks

This session will explore the evaluation of immunogenicity risk for generic peptides and biosimilars, focusing on assessment expectations and evolving regulatory frameworks. Through case studies and expert insights, the session aims to provide a general understanding of current practices used to mitigate immunogenicity risk for these products, including host cell proteins (HCPs) control strategies. Discussions in this session will also touch on in vitro innate immunogenicity studies for follow-on peptides.

Participants:
Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S., Sandoz

Susan Kirshner, PhD
Division Director, Division of Product Quality Assessment XV, Office of Product Quality Assessment III, OPQ, CDER, FDA

Eric Pang, PhD 
Senior Chemist, Division of Therapeutic Performance I, Office of Research Standards, OGD, CDER, FDA

Stacey Ricci, Meng, ScD 
Director, Scientific Review Staff, OTBB, OND, CDER, FDA

Moderator: Anita Krishnan, PhD
Associate Vice President, Head of Analytical Sciences, Biocon Biologics