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In Vitro Immunogenicity Methods for Biosimilars

Tuesday, November 9, 2021

12:00 p.m. - 1:30 p.m.

A more robust understanding of in vitro comparative analytical methods for biosimilars will drive and support more global development and more streamlined requirements for biosimilars. This session will explore the regulatory science FDA needs to conduct to expand the regulatory basis for licensing biosimilars based predominantly on in vitro data. Additionally, this abstract will explore sponsor challenges to developing and implementing such methods.

Moderator: Katie McCarthy
Senior Vice President, Regulatory Affairs, Greenleaf

Emanuela Lacana, PhD
Deputy Director, OTBB, OND, CDER, FDA

Michele Rasamoelisolo, PhD
Senior Director, Head of Specialty Bioanalytics, Teva Pharmaceuticals

Gregor Schaffar
Head of Bioanalytic, Sandoz Inc.

Daniela Verthelyi, M.D., PhD
Chief, Laboratory of Immunology, Division of Biotechnology Review and Research III, Office of Biotechnology Products (OBP), OPQ, CDER, FDA

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