On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab). According to Celltrion, the trial will involve 486 patients with refractory or relapsed multiple myeloma, and will evaluate similarity in pharmacokinetics, efficacy, and safety between Darzalex® and CT-P44.
This follows Celltrion’s announcement of its European IND submission for CT-P44 and entry into the global phase 3 trial procedure in November 2024.