Celltrion announced on July 15 that it has received approval from South Korea’s Ministry of Food and Drug Safety for an investigational new drug (IND) application to conduct a Phase 1 clinical trial of CT-P68, a biosimilar referencing Tremfya (generic name: guselkumab).
The Phase 1 trial will enroll 258 healthy adults to evaluate the safety and demonstrate the pharmacokinetic (PK) equivalence between CT-P68 and the reference product, Tremfya.
Tremfya is an autoimmune disease treatment that selectively inhibits interleukin-23 (IL-23), a protein central to triggering inflammatory responses. It is widely prescribed for conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In 2025, Tremfya's global sales reached approximately $5.1555 billion (about 7.7325 trillion won).
This milestone follows Celltrion's recent Phase 1 IND approvals in both the United States and South Korea for CT-P45, a biosimilar referencing Entyvio (generic name: vedolizumab). Utilizing a distinct mechanism of action, CT-P45 is an integrin inhibitor designed to selectively block the migration of specific immune cells to the intestinal mucosa.
The parallel development of CT-P68 and CT-P45 underscores Celltrion’s strategic initiative to diversify its autoimmune disease portfolio. By expanding beyond traditional TNF-α inhibitors, the company aims to incorporate novel mechanisms of action, including IL-23 and integrin inhibitors.
"We will do our utmost to advance our clinical development seamlessly, further strengthening our competitiveness in the global market while providing patients with a broader range of therapeutic options," a Celltrion official said.
Meanwhile, Celltrion has established a long-term goal to expand its commercialized portfolio from 11 biosimilars currently on the market to 18 by 2030. The company is actively developing a pipeline of follow-on candidates, including the autoimmune therapies CT-P53 (an Ocrevus biosimilar) and CT-P52 (a Taltz biosimilar), alongside the oncology therapeutics CT-P51 (a Keytruda biosimilar) and CT-P44 (a Darzalex biosimilar).
