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FDA accepts Roche’s BLA and grants priority review to Rituxan® for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children. The FDA is yet to approve any treatments for these blood vessel disorders.

Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market.

Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market.

Innovent presents results of efficacy and safety study of BmAb biosimilar at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

Alvotech and Abdi Ibrahim announce partnership for biosimilar development and commercialisation in Turkey. Alvotech will be responsible for development and joint supply alongside Abdi Ibrahim, while Abdi Ibrahim will be responsible for registration and commercialisation of ...

Xbrane and STADA announce expansion of biosimilar development partnership. This expansion will now include the development of Xbrane’s biosimilar candidates certolizumab pegol and nivolumab, as well as other biosimilars.

Tokyo District Court judge dismisses Genentech’s infringement suit against Sandoz and its local marketing partner Kyowa Hakko Kirin.

Results of 24 week switching study released, citing no changes in safety or efficacy outcomes. The study was conducted in patients with moderate to severe rheumatoid arthritis and compared the outcomes of those who swapped to the Sandoz candidate at 24 weeks and those who c...

The EMA accepts Prestige Biopharma’s application for trastuzumab biosimilar Tuznue®.

Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.