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Session 9: Transitions and Interchangeability
Session Chair(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen Inc., United States
The session will span the current state of global discourse on biosimilar product single transitions conducted under medical supervision to the US concept of interchangeability intended to guide pharmacy-level substitution of self-administered biologics. We will start with a review of terminology to level-set and focus on concepts that are globally discussed, but often with confusing terms. International and US perspectives will be contribute to the discussion. If the NOR-SWITCH study results are released, these will be highlighted. If the US FDA draft guidance on interchangeability is released prior to this meeting it will be reviewed.
Speaker(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety, Amgen Inc., United States
Introduction: Terminology - Interchangeability vs Switching vs Transition vs Substitution
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
Immunogenicity of Biologics and Biosimilars
Gino Grampp, PHD
Biosimilars R&D Policy Director, Amgen, United States
Interchangeability: Who Decides? Core principles, Regional Perspectives, and Applications
Stanley SeungSuh Hong, PHD
Senior Advisor, Celltrion Healthcare, Korea, Republic of
Evidence-Based Switching and Interchanging of mAb Biosimilars
Panel Discussion
, All Session Speakers, United States
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Panelist
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