[E-Daily Reporter Hong Ju-yeon ] Celltrion(068270)Celltrion is set to begin full-scale development of “CT-P68,” a biosimilar of “TREMFYA” (generic name: guselkumab), which currently generates 7.73 trillion won in sales.

Celltrion announced on the 15th that it has obtained approval from the Ministry of Food and Drug Safety for its Investigational New Drug (IND) application to conduct a Phase 1 clinical trial for “CT-P68,” a biosimilar of TREMFYA.

Following this approval, Celltrion plans to begin clinical trials involving 258 healthy adults to conduct a comparative study demonstrating the safety and pharmacokinetic (PK) equivalence between the originator drug Tremfya and CT-P68.

Tremfya, the originator drug, is a treatment for autoimmune diseases that works by selectively inhibiting the interleukin (IL)-23 protein, which plays a role in triggering inflammation. It is prescribed for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and its global sales are projected to reach approximately $5.155 billion (about 7.7325 trillion won) by 2025.

Celltrion plans to build an even stronger product portfolio in the autoimmune disease treatment sector through the rapid development of CT-P68. The company already offers a diverse range of treatments for autoimmune diseases in major global markets, including tumor necrosis factor-alpha (TNF-α) inhibitors such as Remsima, Uplima, and Zimpentra (Remsima SC), as well as interleukin (IL) inhibitors such as Stekima and Aptozma.

Recently, the company also obtained IND approval for Phase 1 clinical trials in the U.S. and South Korea for “CT-P45,” a biosimilar of “ENTYVIO” (active ingredient: vedolizumab), a new autoimmune disease treatment with a different mechanism of action. CT-P45 is a treatment in the integrin inhibitor class that selectively inhibits the migration of specific immune cells into the intestinal mucosa.

A Celltrion spokesperson stated, “The development of CT-P68 will further accelerate our efforts to secure new growth drivers in the field of autoimmune disease treatments,” adding, “We will do our utmost to proceed with clinical development without a hitch to continuously strengthen our competitiveness in the global market, while providing patients with a wider range of treatment options.”