• Biosimilar products (Ep. 25)

  • May 13 2024
  • Duración: 17 m
  • Podcast

Biosimilar products (Ep. 25) Por arte de portada

Biosimilar products (Ep. 25)

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  • Resumen

  • 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
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