Biologics Price Competition & Innovation Act of 2009
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Introduction
signed it into law in 2009 as part of the Affordable Care Act
Notes
- created abbreviated licensure pathway for biological products shown to be biosimilar with an FDA-licensed biological product
References
- ↑ FDA News Release. March 6, 2015 FDA approves first biosimilar product Zarxio http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm