Learning Tracks

The Evolution of Biosimilars Assessments: Clinical to Non-Clinical

Tuesday, November 8, 2022

1:00 p.m. - 2:30 p.m.

As analytical methods for evaluating biosimilarity improve, what challenges remain to shifting away from costly, and time-consuming clinical studies? What are the benefits and risks of increasing reliance on analytical data for biosimilars evaluations? Through this session, attendees will understand the benefits of, and challenges to, increasing reliance on analytical data for biosimilars evaluations, as well as recent progression in CMC analytical science and the latest status in biosimilar regulatory pathway evolution.

Moderator: David Gaugh, RPh
Executive Vice President, Sciences and Regulatory Affairs

Steven Kozlowski, M.D.

Director, Office of Biotechnology Products, OPQ, CDER, FDA

Fabrice Romanet, MS, MBA
Senior Vice President, Head of Program Leadership, Regulatory Affairs and Policy – Biosimilars, Fresenius Kabi SwissBioSim GmbH

Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz GmbH

Cory Wohlbach 
Vice President Biosimilars, Teva Pharmaceuticals