Celltrion Enters Clinical Trials for Biosimilar Tremfya, Targeting 7.7 Trillion Won Market

Celltrion announced on the 15th that it has received approval for an Investigational New Drug (IND) application for its biosimilar CT-P68 of Tremfya (generic name Guselkumab), allowing it to commence Phase 1 clinical trials on 258 healthy adults. The trials will compare safety and pharmacokinetic equivalence between the original drug Tremfya and CT-P68. Tremfya, an IL-23 inhibitor treating psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, reported global sales of $5.155 billion in 2022. Celltrion aims to strengthen its portfolio in autoimmune therapies by accelerating CT-P68 development, leveraging its existing global presence with TNF-α and IL inhibitors. Recently, the company also secured IND approvals for CT-P45, a biosimilar of Entyvio (generic name Vedolizumab), an integrin inhibitor targeting specific immune cell migration in the gut.