[Asia Economy Reporter Lee Chun-hee] Celltrion has applied for the European Phase 3 clinical trial plan (IND) for the biosimilar of Actemra (generic name 'Tocilizumab'), 'CT-P47'.
On the 16th (local time), Celltrion announced on the 17th that it had applied to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) for the Phase 3 clinical trial of CT-P47. Currently, Celltrion is conducting Phase 1 clinical trials that began in July last year, and simultaneously plans to start global Phase 3 clinical trials to accelerate the acquisition of clinical results and approval.
This clinical trial is a double-blind, randomized study comparing the efficacy and safety of intravenous (IV) formulations of Actemra and CT-P47 when co-administered with methotrexate in patients with moderate to severe rheumatoid arthritis. A total of 448 subjects will participate in the trial, which is expected to last 13 months. The company aims to submit the product approval application by the first half of 2024. Since the existing Actemra is also available in a subcutaneous (SC) formulation besides IV, Celltrion is developing both IV and SC formulations to allow for selective prescription.
According to Roche, the developer of Actemra, sales of Actemra reached 3.562 billion Swiss francs (approximately 4.56 trillion KRW) last year. Celltrion explained that in addition to rheumatoid arthritis, the target indication of this clinical trial, it aims to expand the market and increase sales through approval for other indications previously approved for Actemra. In particular, Actemra has been used to treat various autoimmune diseases such as cytokine release syndrome (CRS), and has been approved for use as a COVID-19 treatment by the European Medicines Agency (EMA), the World Health Organization (WHO), and the Korea Ministry of Food and Drug Safety.
A Celltrion official said, "With the launch of CT-P47, along with previously launched 'Remsima' and 'Yuflyma', we will establish a strong product lineup in the global autoimmune disease treatment market including rheumatoid arthritis. We will do our best in development to successfully complete the global clinical trials of CT-P47 and ensure that high-quality biopharmaceuticals can be supplied to patients as soon as possible."
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