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Alvotech Debuted on Nasdaq - Big Molecule Watch

Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively.  The debut on Nasdaq follows completion of the company’s business…

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Organon and Henlius license agreement - Big Molecule Watch

Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab).  According to the press release, Henlius independently developed both biosimilar products.  Organon will acquire exclusive global commercialization rights except for China.  The agreement…

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FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).  RIABNI has been approved since December 2020 for treatment of adult patients with…

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BYOOVIZ Launch - Big Molecule Watch

On June 2, 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced  that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing Genentech’s LUCENTIS®, will be available in the United States on July 1, 2022.  BYOOVIZ™ is the first FDA approved ophthalmology biosimilar.  The FDA approved BYOOVIZ™ in September 2021 for the treatment of neovascular…

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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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