Celltrion Confirms Efficacy and Safety of Actemra Biosimilar 'CT-P47' in Phase 3 Trial

Equivalence and Similarity Verification Compared to Original

Celltrion announced on the 15th that it has disclosed the global Phase 3 clinical trial results of the rheumatoid arthritis treatment 'Actemra (generic name: tocilizumab)' biosimilar 'CT-P47' and confirmed its efficacy and safety.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Celltrion's CT-P47 Phase 3 clinical trial was conducted over 52 weeks after the first dose on 471 patients with rheumatoid arthritis (RA). The results disclosed this time are from the clinical data up to 32 weeks.

Celltrion first divided the subjects into two groups: the CT-P47 administration group and the original drug administration group, measuring the change in the 'DAS28' value compared to the baseline, a major indicator of RA activity, as the primary endpoint. DAS28 refers to the disease activity score based on 28 joint counts.

The measurement results showed that the difference between the original drug and the CT-P47 administration group met the pre-defined equivalence criteria. Similar results were confirmed in the secondary endpoints evaluating efficacy, pharmacokinetics, and safety among three groups: ▲ CT-P47 administration group ▲ original drug administration group ▲ group switched from the original drug to CT-P47 from week 24.

Based on the Phase 3 clinical trial results, Celltrion plans to submit approval applications to major regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea as soon as possible.

Actemra is a blockbuster autoimmune disease treatment that recorded global sales of 2.71 billion Swiss francs (approximately 4.05 trillion KRW) last year. It is used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and other conditions.

Actemra is an interleukin (IL)-6 inhibitor that reduces inflammation by suppressing the IL-6 protein involved in triggering inflammation in the body. It is available in two formulations: subcutaneous injection (SC) and intravenous injection (IV). Celltrion’s CT-P47 is also being developed in two formulations, SC and IV, just like the original drug.

A Celltrion official stated, "CT-P47 demonstrated equivalence and similarity to the original drug in the global Phase 3 clinical trial results. Based on these clinical results, we will accelerate the sequential global approval applications and do our best to expand our autoimmune disease portfolio with interleukin inhibitors following tumor necrosis factor alpha (TNF-α) inhibitors such as Remsima and Yuflyma."

Meanwhile, Celltrion plans to sequentially launch five new biosimilar pipelines, including the Actemra biosimilar, starting next year. Through this, the company aims to complete a portfolio of 11 products by 2025.

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