Apotex Sets Stage For Next Fed. Circ. BPCIA Dispute

Law360, New York (October 21, 2015, 10:27 AM EDT) -- Last October, Apotex Inc. filed an abbreviated biologic license application (aBLA) seeking to market a biosimilar version of Amgen Inc.'s Neulasta. Apotex's application was accepted for review in December 2014, and Apotex promptly sent notification to Amgen. Shortly thereafter, Apotex provided Amgen with a copy of its aBLA pursuant to the Biologics Price Competition and Innovation Act's confidentiality provisions and the parties engaged in the BPCIA's patent dance. During that process, Apotex also provided its notice of commercial marketing to Amgen. Apotex's biosimilar pegfilgrastim product has still not yet been approved by the U.S. Food and Drug Administration. Notably, Apotex was the first subsection (k) applicant to actually complete all of the steps of the patent dance....

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