Celltrion announced on Jan. 29 that it has completed its application to the U.S. Food and Drug Administration (FDA) for the approval of CT-P47, a biosimilar to the autoimmune disease treatment drug Actemra (ingredient name: tocilizumab). The application was based on the results of a global Phase 3 clinical trial involving 471 patients with rheumatoid arthritis. CT-P47 seeks approval for indications in rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and COVID-19.
In the clinical trial, patients were divided into two groups: one receiving CT-P47 and the other receiving the original medication. The primary evaluation measured the change in the “DAS28” value from the baseline in rheumatoid arthritis activity. The results showed that the difference between the original drug and the CT-P47 group met the pre-defined criteria for equivalence. Secondary evaluation criteria, assessing the efficacy, pharmacokinetics, and safety of three groups (CT-P47 group, original medication group, and a group that switched from the original medication to CT-P47), also showed similar results.
Leveraging the Phase 3 results, Celltrion plans to accelerate the approval process in other major global markets including Europe and Canada, following the United States. Additionally, after the approval of CT-P47, Celltrion intends to offer it in two forms -- subcutaneous injection and intravenous injection -- just like the original medication Actemra, allowing physicians to choose the best option based on the patient’s condition and convenience.
Actemra, an interleukin inhibitor that reduces inflammation by suppressing the interleukin-6 protein involved in causing inflammation, has shown significant market performance. According to the pharmaceutical market research firm IQVIA, Actemra recorded global sales of about US$2.84 billion in 2022, with the U.S. market alone generating US$1.47 billion during the same period.