On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL) and from the European Commission, in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy. The European approval was recommended in January 2026. The US approval follows the FDA’s priority review.
On the same date, Shanghai Henlius Biotech announced it has received approval from China’s National Medical Products Administration (NMPA) for the investigational new drug (IND) application for HLX18, biosimilar to Opdivo®. This follows the US FDA approval of the IND application for HLX18 in December 2025.
A number of other nivolumab biosimilars have been launched or are in development. Zydus was recently first to market its biosimilar, Tishtha®, in India. At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.