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Scientific Advances in Biosimilar Development
Session Chair(s)
Rachel Turow, JD, MPH
Of Counsel, FDA Regulatory , Skadden, 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
Director, Scientific Review Staff, OTBB, CDER, FDA, United States
Health Canada Update
Denis Arsenault, MBA
Manager, Policy Development, Biologic and Radiopharmaceutical Drugs Directorate,, Health Canada, Canada
Industry Update
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Can a Biosimilar Be Unique? Differentiation Opportunities for Biosimilars
Leah Christl, PhD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Industry Update
Gopinath Ranganna, FFPM
Associate Vice President, Global Clinical Development, Viatris, India
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