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Approval Alert: Celltrion’s Biosimilar Tocilizumab EU-Approved

Feb 24, 2025

On 24 February 2025, Celltrion announced that the European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab).  Avtozma® is approved for all indications of RoActemra®, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).

Celltrion’s Avtozma® is the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Earlier this month, Celltrion’s SC tocilizumab formulation was approved in Korea, following Korean approval of IV tocilizumab in 200mg/10ml and 400mg/20ml formulations in December 2024.

In January 2025, Avtozma® became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).