Welcome to our third episode of the GHAPP & RhAPP biosimilar podcast series! In this episode host Amanda Mixon, PA-C has an in-depth conversation with the incredible Danielle Gatti-Palumbo, PharmD, BCACP, AAHIVP, about The Regulatory Pathway to Biosimilar Approval.
The learning objectives and goals for this episode are to:
-Summarize the totality of evidence approach to determining biosimilarity including:
-Analytical testing for comparative structural and functional characterization
-Nonclinical testing to evaluate the safety profile
-Comparative human pharmacokinetic and pharmacodynamic studies
-Immunogenicity Assessment
-Comparative clinical studies if needed
Please take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval
