On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab) and Winglore™ (ipilimumab) in combination for the treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test. The indication extensions were registered by the TGA on 16 and 19 May 2025, respectively.
The combination therapy for the same indication has been approved in the US (April 2025) and EU (December 2024), and was recommended for NHS funding in the UK (April 2025).
In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer. At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development. On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab).