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BIOCAD Obtains Approval of First Daratumumab Biosimilar

Aug 22, 2025

On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar that has been identified to date worldwide.

There are a number of daratumumab biosimilars currently in development.  In July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44, to 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.

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 completed Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.