Category Archives: Biosimilars

Sandoz Inc. v. Amgen Inc. et al.

SCOTUS No. 15-1039 (decided with 15-1195, Amgen Inc. et al. v. Sandoz Inc.) June 12, 2017 Brief Summary: FC issuance of “a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure” reversed since “the applicant may provide … Continue reading

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Amgen Inc. et al. v. Apotex Inc. et al.

Docket No. 2016-1308 WALLACH, BRYSON, TARANTO July 5, 2016 Update: Petition for a writ of certiorari denied (12/12/16) Brief Summary: DC grant of preliminary injunction against Apotex regarding a biosimilar Neulasta® affirmed (“an applicant must provide a reference product sponsor … Continue reading

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Amgen, Inc. et al. v. Sandoz Inc.

Docket No. 2015-1499 NEWMAN (C/D), LOURIE, CHEN (D) July 21, 2015 Update:  See SCOTUS June 12, 2017 decision reversing the FC regarding 8A (“the applicant may provide [180 day] notice either before or after receiving FDA approval”). Brief Summary: Opinion … Continue reading

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Sandoz Inc. v. Amgen Inc. and Hoffman-La Roche Inc.

Docket No. 2014-1693 PROST, REYNA, HUGHES December 5, 2014 Brief Summary: DC decision of no Article III case or controversy affirmed because Sandoz had not yet filed for approval of its biosimilar to Amgen’s Enbrel®. Summary: Sandoz appealed DC dismissal … Continue reading

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