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FDA Expectations for Demonstration of Interchangeability
Session Chair(s)
Kamali Chance
Chief Regulatory Officer
Biosciences Corporation, United States
Biological products which are biosimilars of reference products are not automatically interchangeable under FDA guidelines. This session will detail our current understanding of FDA expectations for demonstration of interchangeability of a biological product with a reference product with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.
Learning Objective : Compare and contrast biosimilarity versus interchangeability; Describe an overview of FDA expectations for demonstration of interchangeability; Describe standalone versus combined interchangeability study designs.
Speaker(s)
FDA Overview of Considerations in Demonstrating Interchangeability With a Reference Product
Leah Christl, PHD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Industry Perspective of the FDA Interchangeability Guidance
Hillel P Cohen, PHD
Retired, United States
Biosimilars Expert