On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first-line IV treatment of patients with unresectable or metastatic hepatocellular carcinoma.
The combination therapy has previously been approved for HCC in other jurisdictions including Japan (June 2025), the US (April 2025), and the EU (March 2025).
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).