On 23 December 2024, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for all indications of Actemra®, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA).
This news follows Celltrion’s presentation of positive Phase 3 results for CT-P47 in June 2024, and additional Phase 3 data in November 2024, supporting biosimilarity to reference tocilizumab and demonstrating comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis.