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Scientific Advances in Biosimilar Development
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Current biosimilar development timelines are long and ultimately require a clinical study, even though the clinical study is confirmatory. This session will discuss the need for better science to limit the need for clinical data.
Learning Objective : Discuss the challenges to demonstrating biosimilarity without clinical data; Describe the future of biosimilar development and advancing science to speed these products to market.
Speaker(s)
FDA Update
Stacey Ricci, DrSc
FDA, United States
Director, Scientific Review Staff, OTBB, OND, CDER
Health Canada Update
Denis Arsenault, MBA
Health Canada, Canada
Manager, Policy Development, Health Products and Food Branch, Biologic and
Industry Update
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
Can a Biosimilar Be Unique? Differentiation Opportunities for Biosimilars
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Industry Update
Gopinath Ranganna, FFPM
Viatris, India
Associate Vice President, Global Clinical Development
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