On Wednesday, April 26, 2017, the Supreme Court heard the final oral arguments of the 2016 Term. One of the last matters before the Court is the dispute between Sandoz, Inc., and Amgen Inc. regarding the timing of giving notice of commercial biosimilar marketing. The consolidated action is appealing the Federal Circuit’s July 21, 2015 decision holding that Amgen was entitled to an additional 180-day marketing exclusivity period because of Sandoz’s late notification of its intention to market a biologic product that is biosimilar to Amgen’s Neupogen® (see Court interprets biosimilar ‘enigma’ in favor of abbreviated biologic license applicant, July 22, 2015).
Wolters Kluwer will provide a full analysis of the oral arguments, including the questions and comments of newly confirmed Justice Neil Gorsuch, in the next Health Reform WK-EDGE wrap-up; in the meantime, see Biosimilar dispute headed to the Supreme Court, January 17, 2017, for background information about the case, which is rooted in the Biologics Price Competition and Innovation Act (BPCIA), passed as sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).
Companies: Sandoz, Inc.; Amgen Inc.
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