On 11 June 2026, Ono Pharma announced that it submitted a supplemental application for Opdivo® Intravenous Infusion (nivolumab) in Japan, to expand its use for the treatment of unresectable anaplastic thyroid cancer.
Ono first launched Opdivo® in Japan in September 2014 for the treatment of unresectable malignant melanoma. More recently, Opdivo® was approved in Japan in combination with Yervoy® (ipilimumab) for unresectable hepatocellular carcinoma (June 2025).
Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.
A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.