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Renaissance Washington DC Dupont Circle Hotel

Oct 27, 2016 8:15 AM - Oct 28, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Biosimilars 2016

Preview the New Agenda for DIA Biosimilars 2016, the Premier Global Biosimilars Conference.

Session 9: Transitions and Interchangeability

Session Chair(s)

Thomas  Felix, MD

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 If the US FDA draft guidance on interchangeability is released prior to this meeting it will be reviewed.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

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

Hillel P Cohen, PhD

Immunogenicity of Biologics and Biosimilars

Hillel P Cohen, PhD

Sandoz Inc., United States

Executive Director, Scientific Affairs

Gino  Grampp, PhD

Interchangeability: Who Decides? Core principles, Regional Perspectives, and Applications

Gino Grampp, PhD

Amgen, United States

Biosimilars R&D Policy Director

Stanley SeungSuh  Hong, PhD

Evidence-Based Switching and Interchanging of mAb Biosimilars

Stanley SeungSuh Hong, PhD

Celltrion Healthcare, Korea, Republic of

Senior Advisor

Panel  Discussion

Panel Discussion

All Session Speakers, United States

Leah  Christl, PhD

Panelist

Leah Christl, PhD

Amgen, United States

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

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