Celltrion wins IND approval for CT-P68, biosimilar of autoimmune drug Tremfya

Celltrion has received approval to begin a domestic Phase 1 clinical trial for CT-P68, a biosimilar of the autoimmune treatment Tremfya (guselkumab), accelerating its pipeline expansion. The company plans to add the new mechanism-of-action therapy to its existing lineup of TNF-α inhibitors and interleukin inhibitors to strengthen its position in the global autoimmune disease market.

Celltrion said Wednesday it had obtained approval from the Ministry of Food and Drug Safety for an investigational new drug application to conduct the Phase 1 trial of CT-P68.

Under the approval, Celltrion will enroll 258 healthy adults in a comparative study to demonstrate the safety and pharmacokinetic equivalence of CT-P68 against the original drug, Tremfya.

Tremfya is an autoimmune treatment that selectively inhibits interleukin (IL)-23, a protein involved in triggering inflammation. It is prescribed for conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, and posted global sales of approximately $5.16 billion in 2025.

Celltrion has already established a strong foothold in major global markets by supplying autoimmune treatments across two mechanism classes — TNF-α inhibitors including Remsima, Yuflyma and Zymfentra, and interleukin inhibitors including Steqeyma and Eptozma.

The company recently secured IND approval in the United States and South Korea for CT-P45, a biosimilar of the integrin inhibitor Entyvio, and has now entered trials for CT-P68, further diversifying its autoimmune disease portfolio.

Riding record earnings driven by high-margin new products, Celltrion is pressing ahead with follow-on biosimilar development to sustain long-term growth. The company aims to expand its current lineup of 11 biosimilar products to 18 by 2030, and continues to advance a pipeline that includes CT-P53 (Ocrevus), CT-P52 (Taltz), CT-P51 (Keytruda) and CT-P44 (Darzalex).

"The development of CT-P68 will further accelerate our efforts to secure the next wave of growth drivers in the autoimmune treatment space," a Celltrion official said. "We will push forward with clinical development without delay to continuously strengthen our global competitiveness, while doing our utmost to offer patients a broader range of treatment options."