On 15 July 2026, Celltrion announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug application to commence a Phase 1 clinical trial of CT-P68, biosimilar to Janssen’s Tremfya® (guselkumab).
The Phase 1 trial will assess the safety and pharmacokinetic equivalence of CT-P68 and Tremfya® in 258 healthy adults.
No guselkumab biosimilars have yet been approved in any major market. Guselkumab biosimilars are being developed by Polpharma Biologics, whose PB019 is licensed to MS Pharma in the MENA region, and Samsung Bioepis. Alvotech also has a proposed guselkumab biosimilar in development, partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland.