Biogen biosimilar to Roche’s arthritis therapy goes under EU review

Sep. 30, 2022 7:59 AM ETBiogen Inc. (BIIB)RHHBY, RHHBFBy: Dulan Lokuwithana, SA News Editor


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  • Biogen (NASDAQ:BIIB) announced Friday that the European Medicines Agency (EMA) accepted its marketing application for BIIB800, a biosimilar to Roche’s (OTCQX:RHHBY) (OTCQX:RHHBF) arthritis therapy RoACTEMRA.
  • Also known as Actemra or tocilizumab, RoACTEMRA is indicated in Europe for rheumatoid arthritis, idiopathic polyarthritis, and CAT-T cell-induced cytokine release syndrome.
  • In addition, the monoclonal antibody is used to treat adults with COVID-19 who are under systemic corticosteroids and require respiratory support.
  • Biogen (BIIB) has partnered with Chinese pharmaceutical company Bio-Thera Solutions, Ltd for BIIB800.
  • The company has supported its Marketing Authorization Application (MAA) with Phase 3 data for BIIB800, which indicated that the biosimilar candidate outperformed tocilizumab in rheumatoid arthritis patients with inadequate response to anti-rheumatic drug methotrexate.

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