Celltrion Completes Patient Enrollment for Global Phase 3 Clinical Trial of Biosimilar 'CT-P43'

[Asia Economy Reporter Chunhee Lee] Celltrion has completed patient recruitment for the global Phase 3 clinical trial of 'CT-P43,' a biosimilar of the autoimmune disease treatment 'Stelara.'

Celltrion announced on the 18th that it has recruited a total of 509 patients for the global Phase 3 clinical trial of CT-P43, which began in December last year. The company plans to focus on evaluating the safety and efficacy of CT-P43 through the Phase 3 trial. The target completion date for the trial is the second half of next year. Subsequently, Celltrion intends to strive for the commercialization of CT-P43 in line with the expiration of Stelara's substance patents in the US and Europe in September 2023 and July 2024, respectively.

Stelara is an interleukin (IL)-12/23 inhibitor developed by Janssen (a subsidiary of Johnson & Johnson) for the treatment of autoimmune diseases such as psoriasis, Crohn's disease, and ulcerative colitis. It is a blockbuster product that recorded sales of $7.77 billion (approximately 8.76 trillion KRW) based on Johnson & Johnson's management performance last year.

Through the commercialization of CT-P43, Celltrion aims to secure a diverse portfolio in the autoimmune disease treatment market alongside the tumor necrosis factor (TNF)-α inhibitor Remsima product line and Upflima (a biosimilar of Humira).

A Celltrion representative said, "With the completion of patient recruitment for the global Phase 3 clinical trial of CT-P43, we have taken one step closer to commercializing a reasonably priced IL inhibitor drug. We will strive to successfully complete the global trial and expand patients' access to high-quality biopharmaceuticals."

In addition to CT-P43, Celltrion is currently smoothly conducting global Phase 3 clinical trials for several drugs, aiming to obtain approval for at least one drug annually until 2030. These include CT-P16 (a biosimilar of Avastin) for colorectal cancer and non-small cell lung cancer, CT-P42 (a biosimilar of Eylea) for wet age-related macular degeneration and diabetic macular edema, CT-P39 (a biosimilar of Xolair) for allergic asthma and chronic urticaria, and CT-P41 (a biosimilar of Prolia) for osteoporosis.