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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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Lotus and CKD Announce Biosimilar Collaboration

On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure.  According to Lotus’ press…

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Cadila Pharmaceuticals Launches Rituximab and Bevacizumab Biosimilars

BioSimilars Blog

On July 29, 2020, Cadila Pharmaceuticals announced its launch of Rituximab biosimilar Ritucad for the Indian market. Rituximab is used to treat certain types of blood cancers and rheumatoid arthritis. Ritucad was the Indian pharmaceutical company’s second biosimilar launch in July. On July 22, 2020, Cadila announced the launch of…

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