Celltrion to Advance Global Phase 3 Clinical Trial of Autoimmune Disease Drug 'Cosentyx'

Celltrion has officially begun developing a biosimilar of the autoimmune disease treatment Cosentyx.

Novartis' autoimmune disease treatment 'Cosentyx'

On the 1st, Celltrion announced that it had submitted a global Phase 3 clinical trial plan for CT-P55, a biosimilar of Cosentyx under development, to the U.S. Food and Drug Administration (FDA) on the 28th of last month (local time). This clinical trial will compare the efficacy and safety between Cosentyx and CT-P55 over 56 weeks in 375 patients with plaque psoriasis to demonstrate similarity. CT-P55 had previously received approval for a Phase 1 clinical trial in Japan in December last year.

Cosentyx, developed by Novartis, is used to treat psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. Interleukin (IL)-17A, a pro-inflammatory cytokine, causes various inflammatory diseases, and Cosentyx works by directly blocking it. It was first approved by the U.S. FDA in January 2015 and was also authorized in Korea in September of the same year. It is a global blockbuster with global sales of $4.98 billion (approximately KRW 6.8824 trillion) last year. The substance patent is set to expire in January 2029 in the U.S. and January 2030 in Europe, respectively.

With the development of the Cosentyx biosimilar, Celltrion is continuing to expand its autoimmune disease biosimilar portfolio. In particular, in addition to the tumor necrosis factor (TNF) inhibitor class drugs such as Remsima, Simponi, and Upflima, which have shown strong performance, Celltrion is strengthening its portfolio of IL inhibitor class drugs by adding the Stelara biosimilar (CT-P43), an IL-12/23 inhibitor, and now Cosentyx.

Celltrion is also expected to pursue the development of IL-4 inhibitors such as Dupixent in the IL field. Dupixent is a drug used to treat atopic dermatitis and asthma, and it recorded blockbuster sales of €10.715 billion (approximately KRW 15.8602 trillion) last year. In the autoimmune disease field, Celltrion plans to continue developing biosimilars targeting CD-20, CD-38, and integrin α4β7 (LPAM)-1, among others. Through this, the company aims to continuously expand its diverse portfolio in the autoimmune disease treatment area and strengthen its market competitiveness.