July 8, 2016
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 provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), deciding that biosimilar applicants must provide reference product sponsors with notice 180 days before commercial marketing.

In the decision, the Federal Circuit affirmed the district court’s grant of Amgen’s motion for a preliminary injunction. As a result, Apotex must provide its notice of commercial marketing, and delay commercial marketing for 180 days from the date of that notice. Additionally, the Federal Circuit’s decision may effectively extend by six months the 12-year exclusivity that prevents approval of biosimilar applications.

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