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DIA 2018 Global Annual Meeting

FDA Expectations for Demonstration of Interchangeability

    Session Chair(s)
      Kamali  Chance, PhD, MPH, RAC

      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

      FDA Perspective

      Leah Christl, PhD

      • Associate Director for Therapeutic Biologics, TBBS, OND, CDER
      • FDA, United States
      Hillel  Cohen, PhD

      Industry Perspective of the FDA Interchangeability Guidance

      Hillel Cohen, PhD

      • Executive Director, Scientific Affairs
      • Sandoz Inc., United States