Celltrion announced on February 18 that it has received approval from the European Medicines Agency (EMA) for its clinical phase 3 trial plan for CT-P55, a biosimilar to the psoriasis treatment Cosentyx (secukinumab).
Cosentyx, developed by Swiss pharmaceutical giant Novartis, is an interleukin (IL)-17A inhibitor used to treat autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. In 2024, global sales of Cosentyx reached $6.141 billion (approximately 8.6 trillion Korean won). The U.S. patent for Cosentyx is set to expire in January 2029, while the European patent will expire in July 2030.
The approval enables Celltrion to initiate a global phase 3 clinical trial for CT-P55, which will involve 375 patients suffering from plaque psoriasis. The trial aims to compare the efficacy, safety, and equivalence of CT-P55 with Cosentyx. In August 2024, CT-P55 also received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) and is already undergoing a phase 3 trial in the U.S. with the same patient group.
Plaque psoriasis, which affects around 85% of psoriasis patients in South Korea, is characterized by red, scaly patches on the skin, often appearing as coin-sized lesions, sometimes accompanied by white, dandruff-like flakes. Lesions smaller than 5 cm are referred to as localized plaque psoriasis, while those larger than 5 cm are classified as generalized plaque psoriasis.
Through the development of CT-P55, Celltrion aims to strengthen its portfolio in the autoimmune disease treatment market, where it has established a strong presence. The company has already introduced a range of autoimmune disease treatments, including Remsima, Uplayma, Jimpentra, and Steqeyma, which target tumor necrosis factor-alpha (TNF-α) and interleukin inhibitors in key global markets.
A Celltrion representative commented, “With the EMA’s approval of this phase 3 trial, we are moving forward with full-scale clinical development. We are committed to securing the efficacy and safety of CT-P55 through these global trials and to offering patients new treatment options for autoimmune diseases.”
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