On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab). The trial will evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.
In December 2024, Celltrion announced that the US FDA approved its IND application for a global Phase 3 clinical trial of CT-P44, which followed its European IND submission and entry into the global Phase 3 trial in November 2024.
Shanghai Henlius has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15. In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.