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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


FDA Expectations for Demonstration of Interchangeability

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

      Kamali Chance, PhD, MPH, RAC

      • Chief Regulatory Officer
      • Biosciences Corporation, United States
    Biological products which are biosimilars of reference products are not automatically interchangeable under FDA guidelines. This session will detail our current understanding of FDA expectations for demonstration of interchangeability of a biological product with a reference product with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.
    Learning Objective : Compare and contrast biosimilarity versus interchangeability; Describe an overview of FDA expectations for demonstration of interchangeability; Describe standalone versus combined interchangeability study designs.
    Speaker(s)
      Leah  Christl, PhD

      FDA Overview of Considerations in Demonstrating Interchangeability With a Reference Product

      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