Celltrion said the phase 3 clinical trial results CT-P47, a biosimilar referencing Roche’s Actemra (ingredient: tocilizumab), have been published in Rheumatic & Musculoskeletal Disease (RMD Open).

Roche's Actemra is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation in the body, generating global sales of about 2.63 billion French francs (4 trillion won).

In the global phase 3 trial, Celltrion compared the efficacy, pharmacodynamics, pharmacokinetics, and safety of CT-P47 with Actemra. The study involved 471 patients with rheumatoid arthritis and was conducted over 52 weeks, with the published results covering up to week 32.

The primary endpoint of the study was the change in Disease Activity Score 28 (DAS28), a key measure of RA activity, compared to baseline.

The results showed no significant difference between CT-P47 and Actemra, confirming that CT-P47 met the predefined equivalence criteria for efficacy, pharmacokinetics, and safety compared to the reference drug.

At the 24-week mark, patients in the Actemra group were randomly assigned to either continue Actemra or switch to CT-P47 in a 1:1 ratio. Between weeks 24 and 32, efficacy, pharmacokinetics, safety, and immunogenicity were evaluated across three groups: patients who continued Actemra, those who switched to CT-P47, and those who had been receiving CT-P47 since the beginning.

Results across all groups remained consistent, confirming the biosimilar’s equivalence.

Building on these positive results, Celltrion has already filed for regulatory approval of CT-P47 across major markets, including Korea, the U.S., and Europe, covering all indications held by the reference drug.

Celltrion plans to launch both intravenous (IV) and subcutaneous (SC) formulations of CT-P47, mirroring Actemra's two dosage forms, to offer flexibility for healthcare providers based on patient needs.

"CT-P47 demonstrated equivalence and similarity to the original product in this global phase 3 trial,” a Celltrion official said. “Based on these results, we will accelerate approval processes in key international markets.”

The company is committed to expanding its autoimmune disease portfolio with IL inhibitors, building on the success of its TNF-α inhibitors, he added.