Update and scientific strategies for accessing the us market for biosimilars

• At: PSWC, Melbourne (Australia) (2014)
• 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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