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Session 3B: Biosimilars: Evolving Perspectives
Session Chair(s)
Loretta Del Bosco
Director, Regulatory Affairs Quality Assurance Operations
AbbVie Corporation, Canada
Gain an overview from two key North American Regulators from Health Canada and FDA, as well as from the Alliance for Safe Biologic Medicines on the exciting and evolving landscape of Biosimilars. Being at the forefront of the biosimilar discussion is key to the future of our health care system in Canada, and abroad. This session will highlight key concepts and challenges.
Speaker(s)
FDA Update: The Development and Approval of Biosimilar Products in the US
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Understanding Canadian Prescriber Perspectives on Key Considerations for Biologics and Biosimilars
Harry Gewanter
Alliance for Safe Biologic Medicines, United States
Immediate Past Chair
Biosimilars: An Update on Health Canada Activities
Stephanie Hardy, MPH, RAC
Health Canada, Canada
OPIC, Biologics and Genetic Therapies Directorate, HPFB