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Formulary Selection Criteria for Biosimilars in the United States: Focus on Safety, Efficacy, and Manufacturer Capabilities

  • At: 2012 FIP Congress in Amsterdam (the Netherlands)
  • Type: Poster
  • By: GRIFFITH, Niesha (The Arthur G. James Cancer Hospital at The Ohio State University, Columbus, United States of America)
  • Co-author(s): Green, L. (Amgen Inc., Thousand Oaks, United States of America)
  • Abstract:


    BACKGROUND:

    In the United States, the Biologics Price Competition and Innovation Act of 2009 provides an approval pathway for biosimilars. Our objective was to identify key evaluation criteria for formulary inclusion of biosimilars and to develop a checklist for evaluating biosimilars.
    SETTING
    : Hospital pharmacy.
    METHODS:

    Legislation, FDA guidance,

    ..

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Last update 4 October 2019

FIP Congresses