Celltrion Submits Plan for Phase 3 Clinical Trial of Autoimmune Drug 'Cosentyx' in Europe

Celltrion announced on the 14th that it has submitted the clinical trial application (IND) for the global Phase 3 clinical trial of CT-P55, a biosimilar of Cosentyx, to the Clinical Trial Information System (CTIS) managed by the European Medicines Agency (EMA).

Novartis' autoimmune disease treatment 'Cosentyx'

This global clinical trial will be conducted as a comparative study to demonstrate the efficacy and safety equivalence between the original drug and CT-P55 in a total of 375 patients with plaque psoriasis. CT-P55 had previously received IND approval from the U.S. Food and Drug Administration (FDA) for the same study in August.

Cosentyx, an autoimmune disease treatment, is an interleukin (IL)-17A inhibitor used to treat ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. 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 blockbuster drug that recorded global sales of $4.98 billion (approximately 6.747 trillion KRW) last year. Its substance patents are expected to expire sequentially in the U.S. in 2029 and in Europe in 2030.

Celltrion plans to continuously expand its pipeline in the autoimmune disease treatment area to strengthen its market competitiveness. In particular, in addition to the tumor necrosis factor (TNF) inhibitor series such as Remsima, Zimptetra, and Upflima, which have shown strong performance, Celltrion is strengthening its portfolio of IL inhibitor drugs by recently obtaining approval for Stekima, a biosimilar of the IL-12/23 inhibitor Stelara, as well as Cosentyx.

A Celltrion representative said, “With CT-P55 entering the global clinical trial phase, we plan to accelerate the development of this product based on our unparalleled experience and know-how accumulated so far,” adding, “We will build a solid portfolio in the autoimmune disease treatment area, from TNF-alpha (α) inhibitors to interleukin inhibitors, to enhance competitiveness and do our best to secure follow-up pipelines.”