Celltrion Receives Global Phase 3 IND Approval for Actemra Biosimilar 'CT-P47'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 19th that it has received approval for the Phase 3 clinical trial plan (IND) of 'CT-P47', a biosimilar of the rheumatoid arthritis treatment Actemra, from the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

This IND approval was obtained about two months after applying for the CT-P47 IND to URPL in May, and the trial will be conducted on a total of 448 rheumatoid arthritis patients in Europe. Through the Phase 3 clinical trial, Celltrion plans to conduct comparative studies on the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P47 and the original drug Actemra.

Since starting Phase 1 clinical trials of CT-P47 in July last year, Celltrion has completed dosing and is currently analyzing the results. At the same time, the global Phase 3 clinical trial will be accelerated based on this clinical trial plan approval to speed up securing Phase 3 clinical trial results.

The original drug Actemra of CT-P47 is an interleukin inhibitor that reduces inflammation by inhibiting interleukin-6 protein involved in causing inflammation in the body. It is used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. It recorded global sales of approximately KRW 4.56 trillion last year.

Celltrion is developing CT-P47 in two formulations, subcutaneous injection (SC) and intravenous injection (IV), so that medical professionals can choose and prescribe according to the patient's condition and convenience.

A Celltrion official said, "Celltrion plans to lead the market by building a diverse product lineup in the global autoimmune disease market, steadily developing biosimilars of interleukin inhibitors such as Actemra following TNF-α inhibitors represented by Remsima. We will also do our best to accelerate the global Phase 3 clinical trial of CT-P47 to ensure that high-quality biopharmaceuticals can be stably supplied worldwide."

This content was produced with the assistance of AI translation services.