Celltrion Receives IND Approval in Korea for Phase 1 Trial of Tremfya Biosimilar

Expanding Influence in the Global Autoimmune Disease Market

Celltrion announced on July 15 that it has received approval from the Ministry of Food and Drug Safety for its investigational new drug (IND) application to conduct a Phase 1 clinical trial of its biosimilar “CT-P68” to Tremfya (active ingredient: guselkumab).

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

Aerial view of Celltrion Plant 2 in Songdo, Incheon. Photo by Hyunmin Kim

The original drug Tremfya is a treatment for autoimmune diseases that selectively inhibits the interleukin (IL)-23 protein involved in promoting inflammation. As of last year, its global sales amounted to approximately 5.155 billion dollars (about 7.7325 trillion won).

Celltrion plans to quickly develop CT-P68 and further strengthen its product portfolio in the field of autoimmune disease treatments. Recently, the company also received IND approval in both the United States and Korea for a Phase 1 clinical trial of “CT-P45”—a biosimilar to “Entyvio” (active ingredient: vedolizumab) with a different mechanism of action from CT-P68.

Amid record-breaking performance driven by the strong growth of high-margin new products, Celltrion aims to maintain its growth momentum by accelerating the development of follow-up biosimilars and solidifying its leadership in the global autoimmune disease treatment market.

A company representative commented, “We will do our utmost to ensure smooth clinical development, continuously enhancing our competitiveness in the global market while providing patients with a broader array of treatment options.”

This content was produced with the assistance of AI translation services.