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BIOSimilars Law Blog frame

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BIOSimilars Law Blog

The latest updates on biosimilars law as well as informed analysis of this rapidly changing field in the pharmaceutical sector.

Blog Post

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

16 March 16

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for...

Blog Post

FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars

31 August 15

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed...

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