Celltrion Inc. announced Wednesday that Avtozma (CT-P47), its biosimilar of Actemra, a treatment for rheumatoid arthritis (RA), has demonstrated efficacy and safety in a global Phase 3 clinical trial

The results were published in Clinical Drug Investigation.

The 52-week study evaluated the efficacy, pharmacokinetics, safety, and immunogenicity of intravenous CT-P47 in 471 RA patients.

The trial showed similar outcomes across three groups: patients who continued on CT-P47, those who remained on the reference drug, and those who switched from the reference drug to CT-P47.

Celltrion said the findings support CT-P47 as a stable treatment option for long-term use and switching scenarios.

Actemra is an interleukin-6 inhibitor that reduces inflammation by suppressing IL-6 protein activity. The drug posted global sales of about 2.65 billion Swiss francs ($3.3 billion) last year.

Celltrion said the publication is significant as it confirms Avtozma’s long-term efficacy and safety, adding that the company plans to accelerate efforts to expand prescriptions and market share globally based on these results.

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