Celltrion announced on the 18th that it has received approval from the European Medicines Agency (EMA) for the clinical phase 3 trial plan (IND) for the psoriasis treatment Cosentyx (COSENTYX, active ingredient secukinumab) biosimilar.
Cosentyx is an interleukin (IL)-17A inhibitor developed by the Swiss pharmaceutical company Novartis, used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. Last year's global sales for Cosentyx reached $6.141 billion (Hanwha 8.6 trillion won), and the substance patent will expire in the U.S. in January 2029 and in Europe in July 2030.
With this approval, Celltrion will begin a global phase 3 clinical trial for CT-P55, a biosimilar of Cosentyx, involving 375 patients with plaque psoriasis. A comparative study will be conducted to demonstrate the efficacy, safety, and equivalence between Cosentyx and CT-P55. CT-P55 received IND approval from the U.S. Food and Drug Administration (FDA) last August and is currently undergoing global phase 3 trials involving 375 patients with plaque psoriasis.
Plaque psoriasis accounts for about 85% of all psoriasis patients in South Korea. Depending on the size of the lesions, those less than 5 cm may be called localized plaque psoriasis, while those over 5 cm are often referred to as generalized plaque psoriasis. Typically, plaque psoriasis appears as red rashes the size of a 100 won coin throughout the body, including the scalp, accompanied by white, dandruff-like scales and crusts.
Celltrion aims to establish a stronger product portfolio in the area of autoimmune disease treatments, where it currently has existing strengths, through the development of CT-P55. The company has already introduced various autoimmune disease treatments including Remsima, Uplayma, Jimpentra, and Steqeyma, which are tumor necrosis factor-alpha (TNF-α) inhibitors and interleukin inhibitors in major global markets.
A Celltrion official noted, "With the approval of this phase 3 IND, we are embarking on full-scale clinical trials, and we will do our best in development to strengthen our autoimmune disease treatment pipeline," adding, "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."