On 23 December 2025, CSPC Pharmaceutical Group Limited announced that it has obtained approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of its Daratumumab Injection, biosimilar to Johnson & Johnson’s Darzalex®.
The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025. According to BIOCAD, the Russian Ministry of Health approved its Daratumia®, the first daratumumab biosimilar approved in the country.
There are also a number of other daratumumab biosimilars currently under development. In June 2024, Shanghai 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®. In February 2025, Henlius announced that it had entered into a licence agreement with Dr. Reddy’s for HLX15.
In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.