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Session 9 – Biosimilars
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer , Bristol Myers Squibb, United States
There is increasing attention for management of safety information and safety profiles for biosimilar products. Thoughts are evolving, but main issues remain how to distinguish between products, and how similar/dissimilar biosimilars really are from a safety perspective.
In this session, we will explore new thinking and updates on biosimilars. FDA speakers will present on the basics of biosimilars and the scientific approach to demonstrating biosimilarity. Immunogenicity and other safety aspects, as well as naming conventions for biosimilars will also be discussed. Lastly, an industry perspective on issues and specific safety concerns with biosimilar studies will be presented.
Speaker(s)
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Biosimilars 101
Kellie Taylor
Associate Director, OMEPRM, OSE, CDER, FDA, FDA, United States
Naming Conventions of Biosimilars
Jaclyn Bosco, MPH, FISPE
Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States
Issues and Pharmacovigilance Concerns with Biosimilar Studies
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