On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma. Celltrion submitted its IND to the EMA in November 2024.
In July 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety approved its IND application for its global Phase 3 clinical trial of CT-P44, which followed approval of its US IND submission in December 2024.
In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®, the first daratumumab biosimilar approved in the country. This is the first reported regulatory approval for a daratumumab biosimilar worldwide.
Shanghai Henlius also 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®.