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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)
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
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