Celltrion said on the 11th that it won approval from the European Medicines Agency for a change to the clinical trial plan for CT-P55, a psoriasis treatment. CT-P55 is a biosimilar of Cosentyx, developed by Swiss Novartis.
Celltrion is conducting a global phase 3 trial of CT-P55 in patients with plaque psoriasis. The process is aimed at proving the efficacy, safety, and equivalence of Cosentyx and CT-P55. The company plans to reduce the number of patients participating in phase 3 from 375 to 153. It said this could reduce clinical expense and time and lower development costs.
Cosentyx is an autoimmune disease treatment used for plaque psoriasis, ankylosing spondylitis, and more. Cosentyx's sales last year reached $6.668 billion (9.3 trillion won). The substance patents expire in January 2029 in the United States and July 2030 in Europe.
Celltrion plans to strengthen its portfolio by developing CT-P55. Celltrion is introducing a range of autoimmune disease treatments overseas, including Remsima, Yuflyma, Zymfentra, Steqeyma, and Abtosma.
The European Medicines Agency and the U.S. Food and Drug Administration are discussing exempting or streamlining phase 3 trials when the scientific basis is sufficient. A Celltrion official said, "We obtained approval for the clinical change based on our biosimilar development capability and the trust of regulators," adding, "We will respond flexibly to the global environment."