戻る Agenda
Session 7: Switching and Substitution of Biological Products
Session Chair(s)
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)
The Current State of Affairs: Switching, Substitution, and Interchangeability
Laura McKinley, PhD
Pfizer Inc, United States
Director, Global Regulatory Policy and Intelligence
The Science of Substitution
Hans Ebbers, PhD
Biogen Netherlands B.V. , Netherlands
International Scientific Affairs
US Experience to Date
Sameer Awsare, MD
Permanente Medicine, The Permanente Medical Group, United States
FACP Associate Executive Director