Biosimilar products (Ep. 25)

Update: 2024-05-13

Description

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)

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Biosimilar products (Ep. 25)

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Biosimilar products (Ep. 25)

Nathan Teuscher

Biosimilar products (Ep. 25)