On 21 July 2026, GxP News reported that Biocad has received marketing authorisation from Russia’s Ministry of Health for Nivocad®, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of various cancers. This is the first biosimilar nivolumab to be approved in Russia.
Nivocad® is approved for the same indications as the reference product. Nivolumab is included on Russia’s Vital and Essential Drugs list, which allows for increased accessibility for patients.
Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.
Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and NeuClone’s candidate. Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.