16分
Biosimilar products (Ep. 25) Clinical Pharmacology Podcast with Nathan Teuscher
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- 生命科学
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
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
16分