Celltrion Receives European Approval for Phase 3 Clinical Trial of Biosimilar Psoriasis Treatment

Celltrion announced on the 18th that it has obtained approval for the Investigational New Drug application (IND) from the European Medicines Agency (EMA) to conduct global Phase 3 clinical trials for the COSENTYX (active ingredient secukinumab) biosimilar 'CT-P55.'

Based on this approval, Celltrion will initiate global Phase 3 clinical trials involving a total of 375 patients with plaque psoriasis to conduct comparative studies to demonstrate the efficacy, safety, and equivalence between the original drug COSENTYX and CT-P55.

COSENTYX is an interleukin (IL)-17A inhibitor used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. As of last year, COSENTYX's global market sales reached approximately $6.141 billion (about 8.5974 trillion KRW), with its substance patents set to expire in January 2029 in the United States and July 2030 in Europe.

Through the development of CT-P55, Celltrion plans to build a stronger product portfolio in the autoimmune disease treatment sector, where it already holds strengths. The company has established a solid market position by introducing various autoimmune disease treatments ranging from tumor necrosis factor alpha (TNF-α) inhibitors such as Remsima, Yuflyma, Jimptetra, and Stekima to interleukin inhibitors in major global countries.

Additionally, Celltrion recently secured approval for the autoimmune disease treatment Aptozma in major global markets including the United States and South Korea and is preparing for its market launch.

A Celltrion representative stated, "With the approval of the Phase 3 IND, we are entering full-scale clinical trials and will do our best to strengthen our autoimmune disease treatment pipeline. In particular, through global clinical trials, we plan to secure the efficacy and safety of CT-P55 and strive to provide patients with new treatment options."