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Henlius announces that EMA has accepted Henlius’ MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.

Sandoz announces results of Hyrimoz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

FDA approves Amgen’s biosimilar TmAb Kanjinti® for all indications.

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.