Search Results for: "immunex v samsung bioepis etanercept"

Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021.  As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL.  The case had been administratively stayed since January 2020. Judgment…

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Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation (UPDATED)

This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…

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Samsung Bioepis Sued Regarding Its Recently-Approved Etanercept Biosimilar

Yesterday, Immunex, Amgen, and Hoffmann-LaRoche (collectively, “Plaintiffs”) filed a complaint in the District of New Jersey against Samsung Bioepis alleging patent infringement under the BPCIA based on Samsung Bioepis’ submission of an aBLA for a biosimilar of ENBREL® (etanercept).  As we reported yesterday, Samsung Bioepis recently received FDA-approval for that product,…

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BPCIA Litigations

Pending U.S. District Court BPCIA Litigations Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal Amgen v. Hospira, No. 20-201 (D. Del.) NYVEPRIA (pegfilgrastim-apgf) [approved] NEULASTA [litigation #5] Feb. 11, 2020 Pending Genentech v. Samsung Bioepis, No. 20-859 (D. Del.) SB8 (bevacizumab biosimilar) [not approved] AVASTIN [litigation…

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