BPCIA Questions Continue To Arise For Biosimilar Applicants

By Christine Willgoos, John Dillon and Gregory Sephton (July 24, 2017, 4:40 PM EDT) -- On June 12, 2017, the U.S. Supreme Court decided its first case under the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), Sandoz Inc. v. Amgen Inc. (No. 15-1039, 15-1195). The court considered two key provisions of the statute: (1) 42 U.S.C. §262(l)(2)(A), which sets forth that the biosimilar applicant (hereafter "applicant") "shall" provide its application and information that describes the process or processes used to manufacture the biosimilar ("manufacturing information") to a reference product sponsor (hereafter "sponsor") and starts the prelitigation exchange of information commonly known as the "patent dance," and (2) 42 U.S.C. §262(l)(8)(A), which sets forth that the applicant must provide notice of commercial marketing to the sponsor 180 days prior to market launch of the biosimilar....

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