On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of multiple solid tumours. Henlius proposes to commence the clinical trial in the United States when the conditions are met.
Other nivolumab biosimilars already undergoing clinical trials include Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).
In August 2025, Sandoz voluntarily suspended its phase III trial of its nivolumab biosimilar, JPB898, as part of its decision to streamline its clinical trials following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.
Enzene Biosciences sought permission to conduct a phase III trial in India for its nivolumab biosimilar, but was requested to revise its proposed protocol. Also in India, Zydus obtained approval of its ZRCr-4276 but has been prevented from launching due to legal action by BMS.