Tagged as: Sandoz

Sandoz Stipulates to Infringement of Certain Asserted Claims Prior to Etanercept Biosimilar Trial

As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi. Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of…

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New BPCIA Litigation: AbbVie Files Suit on Sandoz's HUMIRA (adalimumab) biosimilar

Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…

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European Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilars

Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira.  Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,…

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Judge Sets Preliminary Injunction Briefing Schedule in Genentech v. Sandoz

We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013.  On April 23, 2018, Judge Renee Marie Bumb held an in-person status conference and set forth a preliminary injunction briefing schedule.  The Court ordered the motion for preliminary…

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Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab).  The CHMP opinion recommends…

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Litigation Update: Case Management Statement in Amgen v. Sandoz (filgrastim, pegfilgrastim)

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…

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