Celltrion Initiates Global Phase 3 Clinical Trial for 'Stelara' Biosimilar

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 20th that it has initiated the global Phase 3 clinical trial of 'CT-P43,' a biosimilar of the autoimmune disease treatment 'Stelara' (active ingredient ustekinumab).

Previously, Celltrion began the Phase 1 clinical trial of CT-P43 in June and is currently conducting the trial. The Phase 3 trial aims to be completed by the second half of 2022.

Through the Phase 3 trial, Celltrion plans to evaluate the safety and efficacy of CT-P43 and strives to commercialize CT-P43 in line with the expiration of Stelara's U.S. substance patent in September 2023 and the European substance patent expiration in July 2024.

Stelara, an interleukin (IL)-12 and 23 inhibitor, is an autoimmune disease treatment developed by Janssen for conditions such as psoriasis, Crohn's disease, and ulcerative colitis. It is a blockbuster product that recorded sales of 7 trillion KRW last year based on the management performance of Johnson & Johnson, Janssen's parent company.

Once the interleukin (IL)-12 and 23 inhibitor CT-P43 is commercialized, Celltrion is expected to secure a diverse portfolio in the autoimmune disease treatment market alongside the TNF-α (tumor necrosis factor-α) inhibitor Remsima (IV, SC) product line and CT-P17 (a Humira biosimilar).

A Celltrion official stated, "Following the TNF-α inhibitor market, Celltrion will lead the global autoimmune disease market by establishing a rich product lineup extending to the interleukin inhibitor market. We plan to successfully complete the CT-P43 trial and continuously supply high-quality biopharmaceuticals worldwide at reasonable prices."

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