Tagged as: eculizumab

Year in Review: Top Legal Developments of 2023

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market.  The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…

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Alexion Sues Samsung over Proposed Eculizumab Biosimilar

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for…

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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S….

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Samsung Bioepis Files Four IPR Petitions on Alexion Eculizumab Patents and One IPR Petition on a Janssen Ustekinumab Patent

Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging…

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Updates on Recent Foreign Approvals and Launches

On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal nocturnal hemoglobinuria (PNH) that had global sales of approximately $5 trillion last year. As the first hematology biosimilar developed by…

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EMA Adopts Positive Opinion for Amgen's Eculizumab Biosimilar Candidate BEKEMV®

European Medicines Agency

On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®.  BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein.  SOLIRIS® is approved for the treatment of paroxysmal…

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Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

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