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Session 9 – Biosimilars
Session Chair(s)
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, 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)
Biosimilars 101
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Naming Conventions of Biosimilars
Kellie Taylor
FDA, United States
Associate Director, OMEPRM, OSE, CDER, FDA
Issues and Pharmacovigilance Concerns with Biosimilar Studies
Jaclyn Bosco, PhD, MPH, FISPE
IQVIA, United States
Vice President and Global Head of Epidemiology