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Session 5:Regulatory Update in Approving Biosimilars and Approach to Interchangeability
Session Chair(s)
Lisa Ruiz, PHD, MBA
VP, Regulatory Affairs Operations, CMC & Device, Abbvie, United States
Sonia Viejobueno, LLM
Associate Director, Regulatory Policy LATAM, Johnson & Johnson Innovative Medicine, Argentina
This session will be a regulatory update of the current trends in approving biosimilars. The US FDA, Anvisa, and Cofepris will discuss their recent regulations, expectations, and experiences approving biosimilars and their approach to interchangeability, understanding the particular challenges in their environment.
Speaker(s)
Daniela Marreco Cerqueira, MS
Associate Director, Third Directorate, ANVISA, Brazil
Regulatory update in APPROVING biosimilars AND APPROACH TO INTERCHANGEABILITY
Cesar Miglioranzza
Regulatory Affairs Manager - LATAM, Novo Nordisk, Brazil
IFPMA Policy Position
Leah Christl, PHD
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States
Considerations in Demonstrating Interchangeability With a Reference Product – FDA Draft Guidance for Industry
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