On 24 February 2026, Ono Pharmaceutical announced that the Korean Ministry of Food and Drug Safety has granted additional approval of Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adults with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This combination was previously approved in Korea for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (July 2025).
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 combination of Opdivo® and Yervoy® has also been approved for colorectal cancer in EU (December 2024), US (April 2025), Australia (June 2025), Canada (August 2025) and Taiwan (January 2026).
Zydus Lifesciences recently successfully opposed BMS’s final appeal in seeking a preliminary injunction in India against Zydus’ nivolumab biosimilar, Tishtha®, the first nivolumab biosimilar in the world to reach market. At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars on the market or 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.