Tagged as: Sandoz

BREAKING: Court Upholds Validity of Enbrel® (etanercept) Patents in Immunex v. Sandoz Suit

Today, in the Immunex v. Sandoz BPCIA litigation, a District of New Jersey judge held that U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product Enbrel®” and U.S. Patent No. 8,163,522, related to Enbrel®’s method of manufacture, are not invalid.  As we previously reported,…

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Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

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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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Sandoz Resubmits Its Biosimilar Pegfilgrastim Application

Last week, Sandoz announced the resubmission of its Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim).  The resubmission is to address an FDA complete response letter that Sandoz received in June 2016.  According to the press release, the resubmission includes new data from a pivotal pharmacokinetics/pharmacodynamics study.  The study compared: …

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Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…

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European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…

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Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to…

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