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

Ask this episode

“What did the council decide on item 42?” — answered with the speaker and the moment.

Transcript

Related