Celltrion, a Korean biotech firm specializing in biosimilars, said it confirmed the safety and efficacy of CT-P47, a biosimilar referencing Roche’s rheumatoid arthritis drug Actemra (tocilizumab), in a global phase 3 study.

The phase 3 study, comparing CT-P47 with Actemra, involved 471 patients with rheumatoid arthritis (RA) over a 52-week period. The most recent findings are based on data collected up to week 32, Celltrion said. 

In the study, Celltrion assessed the alteration in DAS28 values from baseline, a crucial indicator of RA activity, as the primary endpoint in two cohorts: those treated with CT-P47 and those treated with the original drug. 

The study results showed that the variance between Actemra and CT-P47-treated groups satisfied predefined equivalence criteria. 

Comparable outcomes were observed for secondary endpoints, evaluating the effectiveness, pharmacokinetics, and safety across three groups: the CT-P47 arm, the original drug arm, and the CT-P47 switch group initiated at week 24 after the original drug.

Building on the phase 3 findings, Celltrion said it would promptly submit approval applications to major regulatory agencies including the U.S. FDA, European Medicines Agency (EMA), and Korea's Ministry of Food and Drug Safety (MFDS).

Actemra, an autoimmune disease blockbuster treatment, sold 2.7 billion Swiss francs ($3.1 billion) worldwide in 2022. Its indications include rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. 

Actemra reduces inflammation by inhibiting IL-6 protein and is available in both subcutaneous and intravenous formulations. 

Celltrion's CT-P47, mirroring the original drug, is developed in both formulations, offering flexibility for healthcare providers to tailor prescriptions based on patient needs and convenience.

Celltrion hopes to expand its biosimilar product line from the current six to 11 by 2025.