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Goodwin

District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case

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On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”)...more

Venable LLP

Regeneron Dismisses IPR Appeals and Disclaims EYLEA® (aflibercept) Patent

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On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos....more

Goodwin

FDA Accepts Application From Samsung Bioepis and Biogen For Lucentis® (ranibizumab) Biosimilar

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Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis®...more

Goodwin

Biosimilar Clinical Trial Updates

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Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy of its TRUXIMA...more

Goodwin

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

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Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

Patterson Belknap Webb & Tyler LLP

US Biosimilar Pathway Update

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Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

Goodwin

Australian Regulators Approve Samsung Bioepis’s Etanercept Biosimilar Brenzys

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On July 22, 2016, Australia’s Therapeutic Goods Administration approved Samsung Bioepis’s biosimilar of Amgen’s Enbrel (etanercept), which is approved for treatment of rheumatoid arthritis. Samsung Bioepis’s product, called...more

Goodwin

Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

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At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from...more

Goodwin

FDA Accepts Samsung Bioepis’s BLA for Remicade® Biosimilar

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Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments,...more

Patterson Belknap Webb & Tyler LLP

Enbrel Biosimilar in Europe and US

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On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

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