Biosimilar products (Ep. 25)

Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products.

Links discussed in the show:

• FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016)
• FDA Guidance on Demonstrating Interchangeability (May 2019)
• FDA Q&A on Biosimilarity and Interchangeability (Sep 2023)
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter

Copyright Teuscher Solutions LLC

All Rights Reserved