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Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics.  Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to be a BPCIA litigation related to Sandoz and Polpharma’s proposed natalizumab biosimilar.  The asserted…

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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar

Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd).  HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019.  The low-concentration product has been available in various markets outside the United States, with over…

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The Seventh Circuit Affirms Dismissal of the HUMIRA Antitrust Litigation

The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  The appeal is from the Northern District of Illinois’s dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket” around HUMIRA to block…

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Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented…

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Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk)

Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®.  FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which…

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Trial Scheduled for April 2024 in BMS Patent Case Against AstraZeneca Regarding Anti-PDL1 Antibodies

The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb’s (BMS) patent case against AstraZeneca.  BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies.  According to BMS, the case “relates to…

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