On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorised solid tumour indications where Opdivo® (nivolumab) for intravenous infusion is reimbursed.
Opdivo® SC was approved for solid tumour indications in Canada and the EU in May 2025, following similar approvals in the US (December 2024) and UK (April 2025).
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.