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DIA 2021 Global Annual Meeting
Scientific Advances in Biosimilar Development
Rachel Turow, JD, MPH
- Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
- Teva Pharmaceutical Industries Ltd., 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.
Stacey Ricci, DrSc
- Director, Scientific Review Staff, OTBB, OND, CDER
- FDA, United States
Health Canada Update
Denis Arsenault, MA
- Manager, Policy Development
- Health Canada, Canada
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
Gopinath Ranganna, FFPM
- Associate Vice President, Global Clinical Development
- Viatris, India