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DIA 2018 Global Annual Meeting


Global Regulatory Strategies for Biosimilars

    Session Chair(s)
      Oxana  Iliach, PhD

      Oxana Iliach, PhD

      • Senior Director Regulatory Affairs, Biosimilars Center of Excellence
      • IQVIA, Canada
    The number of approvals of biosimilars has increased significantly in both EU and USA over the last three years. However, for some originators there are still only a few biosimilar versions available and up until now there was no overall significant reduction in price in USA as compare to EU. Due to the complexity of biosimilar development, it is not surprising that the biggest and most advanced biotechnological companies remain the major players in the biosimilar field and on average it still takes up to 10 years to develop a biosimilar. Why is there reduced competition from smaller companies from emerging markets? Why do smaller companies seem to struggle when developing biosimilar products for the global market? What obstacles are preventing smaller companies from entering the EU and USA to help drive down the price of expensive originator biologics? The goal of this session is to explore these major questions using case studies of three biosimilars development of the same monoclonal antibody developed in emerging markets
    Learning Objective : Provide an overview of a successful regulatory strategy which, if used properly, will reduce biosimilar development time to allow the sponsor to get biosimilar to market faster. Identify common mistakes in biosimilar development that significantly increase time of overall development.
    Speaker(s)
      Brittany  Scott

      The Evolving Regulatory Guidelines for Biosimilars and Biologics

      Brittany Scott

      • Creative Director
      • Addison Whitney, United States
      Yatika  Kohli, PhD

      To be determined

      Yatika Kohli, PhD

      • Vice President, Regulatory Affairs
      • Medicago Inc, Canada