18 min listen
Biosimilar products (Ep. 25)
Biosimilar products (Ep. 25)
ratings:
Length:
17 minutes
Released:
May 13, 2024
Format:
Podcast episode
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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Copyright Teuscher Solutions LLC
All Rights Reserved
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
Released:
May 13, 2024
Format:
Podcast episode
Titles in the series (25)
Comparing NCA and PK models (Ep. 3) by Clinical Pharmacology Podcast with Nathan Teuscher