The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing.
The ruling weighed in on a key...more
7/11/2016
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Preliminary Injunctions
Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more