On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as intravenous infusion for first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
This follows closely behind approvals of the same indication in Korea (July 2025), Japan (June 2025), the US (April 2025), and the EU (March 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.
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development. In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).