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Coherus Announces FDA Approval of CIMERLI (ranibizumab-eqrn)

On August 2, 2022,  Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity.  Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion…

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Alvotech Announces Positive Top-Line Results from Clinical Trial for Ustekinumab Biosimilar

On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…

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Alvotech and BiosanaPharma Enter Exclusive Global Licensing Agreement for AVT23

Alvotech Holdings S.A. (“Alvotech”) announced that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate to severe persistent asthma or chronic idiopathic urticaria….

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Celltrion Seeks EMA Approval for Avastin Biosimilar

The Korea Herald has reported that Celltrion Inc., a South Korean biopharmaceutical firm, is seeking approval from the European Medicines Agency (EMA) for the sale of CT-P16, Celltrion’s anticancer biosimilar candidate.  CT-P16 references Avastin (Bevacizumab), which is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney…

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Amneal Acquires Kashiv Specialty Pharmaceuticals

On April 5, 2021, , Inc. (“Amneal”) and Kashiv BioSciences LLC (“Kashiv”) announced that Amneal’s wholly-owned subsidiary, Amneal Pharmaceuticals LLC, has completed its acquisition of a 98% interest in Kashiv’s wholly-owned subsidiary, Kashiv Specialty Pharmaceuticals, LLC (“Kashiv Specialty”).  According to the release, Amneal has a portfolio of more than 250…

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Sanofi to Acquire Kymab for up to $1.45 Billion

Sanofi announced that it has entered into an agreement to acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones.  The acquisition…

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Election Day in the US

In observance of Election Day, Goodwin’s US offices are closed on Tuesday, November 3. We encourage everyone in our community to do their civic duty and vote. The BMW blog will be back on Wednesday, November 4.

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