On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).
The approval follows those for Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) and Fresenius Kabi’s Tyenne® (tocilizumab-aazg), both in September 2023. Tyenne® was launched in the US in an IV formulation in April 2024 and in a subcutaneous formulation in July 2024.
Celltrion’s Aptozma™ was the first tocilizumab biosimilar to be approved in Korea in December 2024. The biosimilar, marketed as Avtozma® in the EU, received a positive recommendation by the EMA’s CHMP in December 2024.