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Update and scientific strategies for accessing the us market for biosimilars

  • At: 2014 FIP Congress in PSWC, Melbourne (Australia)
  • Type: Presentation
  • By: O'CONNOR, Anita (ANITA O'CONNOR CONSULTING, Hoffman, United States of America)
  • Abstract:

    The passage of the Affordable Care Act in 2012 provided a legal pathway for biosimilar marketing approvals in the U.S. Since the law was enacted, the U.S. Food and Drug Administration (FDA) published 4 guidelines on biosimilars. These guidelines are used to develop biosimilars for the U.S. market and have some features that are unique from a

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Last update 4 October 2019

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