On 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the 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 Opdivo® as adjuvant treatment after surgery.
Opdivo® was previously approved in Taiwan for a number of indications, including, in combination with BMS’ Yervoy® (ipilimumab), for unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC) and unresectable or metastatic hepatocellular carcinoma, and in combination with cisplatin and gemcitabine, for unresectable or metastatic urothelial carcinoma.
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, and Boan Biotech’s BA1104.