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Amneal Launches RELEUKO (filgrastim-ayow) in the United States

On November 22, 2022, Amneal Pharmaceuticals, Inc. (“Amneal”) announced the commercial launch of RELEUKO, a biosimilar referencing Neupogen.  RELEUKO is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy.  RELEUKO is Amneal’s second U.S. biosimilar launch.  As we previously reported, Amneal announced the launch of its first…

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Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition.  In July 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services…

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Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Samsung’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). On September 7, 2022, Genentech and Samsung filed…

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Sandoz New Global "Act4Biosimilars" Initiative - Big Molecule Watch

On May 31, 2022, Sandoz announced the launch of a new global initiative called “Act4Biosimilars” to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by…

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Regeneron Files Antitrust Lawsuit - Big Molecule Watch

Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware.  Regeneron alleges that “Amgen is engaged in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).”  According to Regeneron,…

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Samsung Biologics Completes Full Acquisition of Samsung Bioepis

In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics.  On April 20, 2022, Samsung Biologics and Biogen announced that Samsung Biologics has now fully acquired Samsung Bioepis for a total consideration of USD…

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OcyonBio Announces Biosimilar Solutions to Begin GMP Manufacturing in Puerto Rico

Last week, OcyonBio announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. in Puerto Rico. According to the press release “OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing, including process development, plasmid DNA, viral…

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