We are updating our Privacy Policy and Terms and Conditions to help you clearly understand how your personal information is collected, stored and managed. Learn More
Menu Back toBiosimilars-Demonstrating-Structural-and-Functional-Similarity

DIA 2018 Global Annual Meeting

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


Biosimilars: Demonstrating Structural and Functional Similarity

    Session Chair(s)
      Emily  Shacter, PhD

      Emily Shacter, PhD

      • Independent Consultant
      • ThinkFDA, LLC, United States
    Biosimilar products continue to advance, with many companies investing in this field. The biosimilarity paradigm is based on reducing clinical and non-clinical data to the extent possible, based on robust comparison of the biosimilar product versus the authorized reference medicine. This session will look at the quality foundation for building the biosimilarity exercise and elaborate on experiences gained with authorized products and those in development. The utility of physicochemical and bioassays for characterization will be highlighted with a focus on monoclonal antibodies as example.
    Learning Objective : Discuss analytical and functional assays used to develop a biosimilar monoclonal antibody; Identify how robust quality characterization data may enable reduction of clinical requirements; Describe an awareness of technical challenges and regulatory thinking related to biosimilarity at quality level.
    Speaker(s)
      Richard  Markus, MD, PhD

      Biosimilar Development: The Product Defines the Process

      Richard Markus, MD, PhD

      • Vice President, Global Development
      • Amgen Inc., United States
      Rajesh  Ullanat

      Industry Perspective

      Rajesh Ullanat

      • Head, Global Biologics Scientific Affairs
      • Mylan Pharmaceuticals, India
      Christopher  Downey, PhD

      FDA Perspective

      Christopher Downey, PhD

      • Review Chief, OBP, OPQ, CDER
      • FDA, United States