On 13 October 2026, Xbrane Biopharma announced that patient enrolment has completed for a clinical trial of Xdivane™, Xbrane’s biosimilar to BMS’ Opdivo® (nivolumab). The trial is sponsored by Intas, which is jointly developing Xdivane™ with Xbrane under a November 2024 global licensing and co-development agreement.
The streamlined, combined phase 1/3 trial enrolled its first patient in November 2025. It aims to compare the pharmacokinetics, efficacy, safety and immunogenicity of Xdivane™ versus Opdivo® in 340 patients with resected melanoma. Xbrane previously reported that the FDA and EMA had both supported the streamlined combined Phase I/3 trial.
Amgen became the first known company to file a US application for an Opdivo® biosimilar, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026. Multiple nivolumab biosimilars are also under development, including Sandoz’s JPB898, , Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.
To date, the only country in which it is reported that nivolumab biosimilars have launched is India, a less regulated market. The two nivolumab biosimilars launched in India are Zydus’ Tishtha™ (January 2026) and Dr Reddy’s Nivorz® (September 2026).