Celltrion(068270) will embark on developing a biosimilar to the autoimmune disease treatment "Tremfya (ingredient name guselkumab)."
Celltrion said on the 15th that it received approval from the Ministery of Food and Drug Safety for a phase 1 clinical trial plan (IND) for the Tremfya biosimilar "CT-P68."
The company plans to conduct a phase 1 clinical trial comparing the safety and pharmacokinetics (PK) of the original drug and CT-P68 in 258 healthy adults.
Tremfya is an autoimmune disease treatment targeting interleukin (IL)-23 and is used for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. According to the industry, last year's global sales were about $5.1 billion (about 7.7 trillion won).
Celltrion plans to expand its autoimmune disease biosimilar portfolio through this development. The company is currently selling "Remsima," "Yuflyma," and "Steqeyma," and recently its Entyvio biosimilar "CT-P45" also won phase 1 approval in Korea and the United States.
Celltrion currently sells 11 biosimilars and aims to expand the number of products to 18 by 2030.