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Session 5:Regulatory Update in Approving Biosimilars and Approach to Interchangeability
Session Chair(s)
Lisa Ruiz
Senior Director,Latin America Area Head, Regulatory International
Abbvie, United States
Sonia Viejobueno, LLM
US and Latin America Policy Lead, Global Regulatory Policy and Intelligence
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)
Regulatory update in APPROVING biosimilars AND APPROACH TO INTERCHANGEABILITY
Daniela Marreco Cerqueira, MS
ANVISA, Brazil
Associate Director, Third Directorate
IFPMA Policy Position
Cesar Miglioranzza
Novo Nordisk, Brazil
Regulatory Affairs Manager - LATAM
Considerations in Demonstrating Interchangeability With a Reference Product – FDA Draft Guidance for Industry
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
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