In this webinar...
The term "interchangeable" when applied to biosimilars has different meanings in different parts of the world. This webinar will provide a review of terminology, including differences in US and EU, definitions of interchangeability, and regulatory and legal frameworks as they relate to substitution of biologics. The US FDA draft guidance for industry on "Considerations in Demonstrating Interchangeability with a Reference Product" will be discussed, highlighting data expectations and noting remaining areas of uncertainty.
- Explain the meaning of Interchangeability in the US and the EU
- Describe the difference between physician-mediated switching and pharmacy-level substitution
- Express a broad understanding of US expectations for demonstration of interchangeability
- Laura McKinley, PhD, Director, US Regulatory Policy Lead, Pfizer Essential Health, Pfizer, Inc
- Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz, Inc.