FDA Expectations for Demonstration of Interchangeability
Kamali Chance, PhD, MPH, RAC
CEO and Executive Consultant
KC Biopharma Consulting, LLC, United States
This session will detail our current understanding of FDA expectations for demonstration of interchangeability with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.
Learning Objective : Defining bioimilarity versus interchangability; Describe an overview of FDA expectations for demonstration of interchangeability; Describe standalone versus combined interchangeability study designs.
Leah Christl, PhD
Associate Director for Therapeutic Biologics, TBBS, OND, CDER
FDA, United States
Industry Perspective of the FDA Interchangeability Guidance
Hillel Cohen, PhD
Executive Director, Scientific Affairs
Sandoz Inc., United States