On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20)), has been approved in Europe and Canada across multiple solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (Yervoy®), and in combination regimens with chemotherapy.
The European approval follows the CHMP recommendation earlier in May 2025. The EU and Canada join the US and UK in approving the subcutaneous formulation.
At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.