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)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.