Biosimilars Conference

Session Chair(s)

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)