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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 If the US FDA draft guidance on interchangeability is released prior to this meeting it will be reviewed.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)
Introduction: Terminology - Interchangeability vs Switching vs Transition vs Substitution
Thomas Felix, MD
Amgen Inc., United States
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Immunogenicity of Biologics and Biosimilars
Hillel P Cohen, PhD
Sandoz Inc., United States
Executive Director, Scientific Affairs
Interchangeability: Who Decides? Core principles, Regional Perspectives, and Applications
Gino Grampp, PhD
Amgen, United States
Biosimilars R&D Policy Director
Evidence-Based Switching and Interchanging of mAb Biosimilars
Stanley SeungSuh Hong, PhD
Celltrion Healthcare, Korea, Republic of
Senior Advisor
Panel Discussion
All Session Speakers, United States
Panelist
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy