On 11 June 2026, Xbrane Biopharma and JOINN Biologics US announced that they have entered into a strategic partnership to develop Xbrane’s Xdarzane™, biosimilar to J&J’s Darzalex® (daratumumab).
Under the agreement, US-based Contract Development & Manufacturing Organisation (CDMO), JOINN Biologics, will provide “customised process development” of the Xbrane biosimilar and will be responsible for further pilot scale process development to demonstrate analytical similarity of Xdarzane™ to Darzalex® and deliver a commercially viable process yield. Xbrane will be responsible for global out-licensing activities to commercial partners. Subsequent development steps will then be conducted by Xbrane and JOINN, including scale-up, clinical development, regulatory filing and commercial manufacturing.
The first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025. Daratumumab biosimilars are under development by Celltrion (CT-P44), Henlius (HLX15/HLX15-SC), and CSPC. In February 2025, Henlius announced it had entered into a licence agreement with Dr Reddy’s for commercialisation of both SC and IV formulations of HLX15 across 42 European countries and the United States. Henlius dosed its first patient in a phase 1 clinical trial of HLX15-SC (daratumumab SC) in May 2026.