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BREAKING NEWS: Federal Circuit Affirms Sandoz’s Victory Over Amgen in Filgrastim and Pegfilgrastim Biosimilar Patent Litigation

This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar.  As we previously reported, in December 2017 the Northern California district court granted summary…

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Taiwan-based EirGenix and Sandoz Partner to Commercialize EirGenix’s Trastuzumab Biosimilar

Taiwan-based EirGenix, Inc. and Sandoz recently announced that they have entered into an agreement, giving Sandoz an exclusive license to commercialize EirGenix’s proposed biosimilar version of Roche’s Herceptin (trastuzumab), which is now in in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast…

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US DOJ Urges Striking Down Entire ACA

As previously reported, in December 2018, the District Court for the Northern District of Texas in Texas v. United States issued an order declaring that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, that the remaining provisions of the ACA are not severable from the mandate provision,…

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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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Federal Circuit Round Up: Epoetin Alfa, Adalimumab, Rituximab

April has seen a flurry of biosimilar-related appellate activity before the Federal Circuit. Below are some highlights. The parties in the Amgen v. Hospira BPCIA litigation concerning Hospira’s RETACRIT (epoetin alfa-epbx) biosimilar concluded appellate briefing this month.  As we previously reported, Hospira is appealing the district court’s adverse judgment that…

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FDA Approves Second Etanercept Biosimilar

The U.S. FDA has approved ETICOVO™ (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL®, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in patients aged 4 years or older.  These are the same indications for which…

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Alvotech and Fuji Pharma Partner to Commercialize Alvotech’s Ustekinumab Biosimilar

Earlier this month, Alvotech announced that it entered into an agreement with Fuji Pharma, giving Fuji Pharma the exclusive right to commercialize its biosimilar of Stelara® (ustekinumab) in Japan.  The press release states that, in exchange for developing and providing Fuji Pharma with a commercial supply of its ustekinumab biosimilar, Alvotech will…

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Amgen Answers Coherus’s Adalimumab Complaint

As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita™, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States.  As we also reported, Coherus amended its…

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