Celltrion Reveals Additional Research Results on Actemra Biosimilar for the '4 Trillion Won Market'

Celltrion announced on the 21st that the Phase 3 clinical trial results of CT-P47, developed as a biosimilar to Actemra, a treatment for rheumatoid arthritis (RA), have been published in Rheumatology and Musculoskeletal Disorders Open (RMD Open). RMD Open is the official journal of the European League Against Rheumatism (EULAR) and a rheumatology journal of the British Medical Journal (BMJ), recognized as the world's most authoritative journal in the field of rheumatology and musculoskeletal diseases.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

This study covers up to 32 weeks of the global Phase 3 clinical trial of the intravenous formulation of CT-P47 conducted over 52 weeks on 471 patients with rheumatoid arthritis. The clinical results confirmed equivalent efficacy of CT-P47 compared to the original drug by meeting the pre-defined equivalence criteria in the primary efficacy endpoint. Similarity was also confirmed in safety and pharmacokinetic characteristics. In the secondary endpoints evaluating efficacy, pharmacokinetics, safety, and immunogenicity among three groups?the experimental group switched from Actemra to CT-P47 at week 24, the control group continuing Actemra treatment, and the main CT-P47 treatment group?similar results were observed across all groups.

Actemra is an autoimmune disease treatment developed by the Swiss multinational pharmaceutical company Roche. It reduces inflammation by inhibiting interleukin (IL)-6, a protein that causes inflammation in the body. Besides rheumatoid arthritis, it is used to treat giant cell arteritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. Last year, it formed a massive market with global sales approaching 2.63 billion Swiss francs (approximately 4 trillion KRW). Especially since Actemra is available in both intravenous and subcutaneous formulations, CT-P47 is also being prepared for launch in these two formulations to allow healthcare professionals to prescribe selectively.

Based on these clinical results, Celltrion completed the application for marketing authorization of CT-P47 for all indications held by Actemra to major regulatory agencies, including the U.S. Food and Drug Administration (FDA) in January and the Ministry of Food and Drug Safety (MFDS) in Korea in February.

A Celltrion official stated, “CT-P47 demonstrated equivalence and similarity to the original drug in the global Phase 3 clinical trial,” adding, “Based on these clinical results, we will accelerate ongoing approval applications in major overseas countries and do our best to expand our autoimmune disease portfolio with IL inhibitors following the previously launched tumor necrosis factor (TNF)-alpha inhibitors.”