On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for rheumatoid arthritis (RA). In the same announcement, Celltrion also confirmed that its intravenous (IV) Aptozma™ in 80 mg/4ml formulation received approval.
According to Celltrion, this approval completes its Aptozma™ line up in Korea following approval of IV Aptozma™ in 200mg/10ml and 400mg/20ml formulations in December 2024. The December approval marked the first tocilizumab biosimilar approved in Korea.
In January 2025, Aptozma™ 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).