On 18 October 2026, the Economic Times reported that Lupin has received marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its nivolumab biosimilar, referencing BMS’ Opdivo®. No launch plans have been announced to date.
The biosimilar is approved for the same indications as the reference medicine, with the approval subject to Lupin conducting a Phase IV (post-marketing) study in India. The approval was granted based on positive results from a local Phase III clinical trial, demonstrating comparable pharmacokinetics, efficacy and immunogenicity of the biosimilar with BMS’ Opdivo®.
Lupin will manufacture the biosimilar in partnership with Virchow Biotech, a contract development and manufacturing organisation (CDMO) headquartered in India.
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). This was followed by the Indian launch of the Dr Reddy’s nivolumab biosimilar Nivorz™ in September 2026.
Amgen is the first known company to file an application with the FDA for a biosimilar to BMS’ Opdivo®, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026. Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.