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
No persons identified in this episode.
This episode hasn't been transcribed yet
Help us prioritize this episode for transcription by upvoting it.
Popular episodes get transcribed faster
Other recent transcribed episodes
Transcribed and ready to explore now
3ª PARTE | 17 DIC 2025 | EL PARTIDAZO DE COPE
01 Jan 1970
El Partidazo de COPE
13:00H | 21 DIC 2025 | Fin de Semana
01 Jan 1970
Fin de Semana
12:00H | 21 DIC 2025 | Fin de Semana
01 Jan 1970
Fin de Semana
10:00H | 21 DIC 2025 | Fin de Semana
01 Jan 1970
Fin de Semana
13:00H | 20 DIC 2025 | Fin de Semana
01 Jan 1970
Fin de Semana
12:00H | 20 DIC 2025 | Fin de Semana
01 Jan 1970
Fin de Semana