Search Results for: "amgen v. hospira"

Test 2 - FDA Approvals

Filgrastim+ Biosimilar: ZARXIO (filgrastim-sndz) Applicant: Sandoz Reference Product: NEUPOGEN [#1] aBLA Approval: Mar. 6, 2015 US Launch: Sept. 3, 2015 [#1] Related BPCIA Litigation: Amgen v….

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Test 2 - BPCIA Litigations

Pending U.S. District Court BPCIA Litigations Bevacivumab+ Genentech v. Samsung Bioepis, No. 20-859 (D. Del.) Accused Biosimilar [status]: SB8 (bevacizumab biosimilar) [not approved] Reference…

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Test 2 - Appeals

Completed Federal Circuit Appeals: Etanercept+ Sandoz v. Amgen, No. 14-1693 Biologic: Etanercept Appeal from: C.A. No. 13-2904 (N.D. Cal.) Disposition: Dismissal of Sandoz’s declaratory judgment…

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