On 4 November 2025, Xbrane Biopharma announced that the first patient has been enrolled in the clinical trial of Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab). The trial is sponsored by Intas, which entered into a global licence agreement with Xbrane for Xdivane™ in November 2024. Xbrane previously reported that the FDA and EMA had both supported a streamlined combined Phase I and III trial.
Xdivane™ is one of several nivolumab biosimilar candidates lining up to compete with BMS’ Opdivo®. Others include Amgen’s ABP 206, Reliance Life Science’s RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276. In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.