On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent as adjuvant treatment after surgery.
Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.
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. In July 2026, Biocad’s Nivocad® received marketing approval in Russia.
A number of 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, NeuClone’s candidate and Shilpa’s intravenous nivolumab biosimilar. Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.
BMS’ patent rights for nivolumab are being challenged, including in the EU where EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma, was revoked in July 2026 following an opposition by 5 “strawperson” opponents.