Celltrion gets green light for Phase 1 clinical trial of 'Tremfya' biosimilar in South Korea

Jul 15, 2026, 09:58 am

Celltrion announced on July 15 that it has obtained Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial of "CT-P68," a biosimilar of "Tremfya" (ingredient name: guselkumab).

Following this approval, Celltrion will initiate clinical procedures targeting 258 healthy adults to conduct a comparative study aimed at demonstrating safety and pharmacokinetic (PK) equivalence between the original drug, Tremfya, and CT-P68.

The original drug, Tremfya, is an autoimmune disease treatment that selectively inhibits the interleukin (IL)-23 protein, which causes inflammation. It is primarily used to treat plaque psoriasis, Crohn's disease, and ulcerative colitis. In 2025, its global sales reached approximately $5.155 billion (approx. 7.7325 trillion won).

Celltrion plans to swiftly develop CT-P68 to further strengthen its pipeline of autoimmune disease treatments. The company is diversifying its portfolio, adding to its already-marketed TNF-α inhibitors like "Remsima," "Yuflyma," and "Zymfentra," as well as interleukin inhibitors such as "Steqeyma" and "Aptozma."

Recently, the company also secured Phase 1 clinical trial approvals in the United States and South Korea for "CT-P45," a biosimilar of "Entyvio" (vedolizumab), an autoimmune disease treatment with a different mechanism of action. CT-P45 is an integrin inhibitor class treatment that selectively blocks the migration of specific immune cells into the intestinal tract.

"With the development of CT-P68, we have gained further momentum in securing next-generation growth engines in the field of autoimmune disease treatments," a Celltrion official said. "We will do our best to carry out the clinical development without any hitches, consistently strengthening our global market competitiveness while providing patients with a wider range of treatment options."

Moon Jeong-woo

#Celltrion