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