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Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021.  Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) i...

MSD published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma.  According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survi...

Shanghai Henlius Biotech announced that China’s NMPA has approved its biosimilar rituximab (汉利康®)), as the first biosimilar approved in combination with methotrexate for the treatment of adult patients with rheumatoid arthritis  who have inadequate response to one or mor...

The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog...

FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biological product development and regulatory science”.

Shanghai Junshi Biosciences announced that China’s NMPA has approved its biosimilar adalimumab product (50mg/ml) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.  The product was jointly developed by Shanghai Junshi Biosciences and Jiangsu T-...

Celltrion launched Yuflyma® (high concentration citrate-free biosimilar adalimumab) in Korea.

AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments.  This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portf...

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar p...