On 12 January 2026, Ono Pharmaceutical announced that the Taiwan Food and Drug Administration has approved a new indication for Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This combination was previously approved in Taiwan in July 2025 for the first-line treatment of unresectable or metastatic hepatocellular carcinoma.
In 2011, Ono granted BMS commercialisation rights for Opdivo® excluding in Japan, South Korea and Taiwan, where Ono retains all rights. In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.
The Opdivo®/Yervoy® combination has also been approved for the same indication in EU (December 2024), US (April 2025), Australia (June 2025) and Canada (August 2025).
At least Zydus Lifesciences, Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in development. Ipilimumab biosimilars are also on their way, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.