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Biosimilars Conference


Session 7: Switching and Substitution of Biological Products

Session Chair(s)

Laura  McKinley, PhD

Laura McKinley, PhD

  • Director, Global Regulatory Policy and Intelligence
  • Pfizer Inc, United States
The term interchangeable has different meanings in different parts of the world. The session will begin with a brief review of terminology, including differences in US and EU definitions of interchangeability, and what has changed in the US with the finalization of guidance. The session will go beyond discussing the regulatory frameworks that support switching and substitution of biological products. The session will discuss the science supporting switching and substitution of biological products, experience to date with a focus on the US marketplace, and the anticipated value and impact of the interchangeability designation in the US.
Learning Objective : Upon completion of this session, the participant should be able to:
  • Understand the meaning of interchangeability in US and EU
  • Understand the difference between physician-mediated switching and pharmacy-level substitution
  • Gain a broad understanding of the considerations influencing the value of interchangeability in the US marketplace

Speaker(s)

Laura  McKinley, PhD

The Current State of Affairs: Switching, Substitution, and Interchangeability

Laura McKinley, PhD

  • Director, Global Regulatory Policy and Intelligence
  • Pfizer Inc, United States
Hans  Ebbers, PhD

The Science of Substitution

Hans Ebbers, PhD

  • International Scientific Affairs
  • Biogen Netherlands B.V. , Netherlands
Sameer  Awsare, MD

US Experience to Date

Sameer Awsare, MD

  • FACP Associate Executive Director
  • Permanente Medicine, The Permanente Medical Group, United States

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