Tagged as: Pfizer

GSK Sues Pfizer for Patent Infringement over RSV Vaccine

GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY.  According to the complaint, AVREXY and ABRYSVO were approved by the U.S….

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Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents

Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to…

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HUMIRA (adalimumab) Biosimilar Launches

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb).  With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…

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Alnylam Files New COVID-19 Vaccine Infringement Lawsuits Against Pfizer and Moderna

Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam’s patent rights. The patents-in-suit are U.S. Patent…

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Update on Arbutus mRNA Vaccine Patent Litigations

Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE. Arbutus/Genevant allege that Pfizer/BioNTech’s COVID-19 vaccine and any COVID-19 mRNA LNP vaccine products infringe five Arbutus/Genevant patents “relating to nucleic acid-lipid…

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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

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Pfizer Files Lawsuit in Australia to Halt Sales of BRENZYS (etanercept)

Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept).  Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled “Production of polypeptides,” with claims directed to cell…

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FDA Approves Amneal’s ALYMSYS (bevacizumab-maly)

On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN.  The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…

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Amgen and Pfizer Developing More Interchangeable Biosimilars

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab).  Pfizer also…

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