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Approval Alert: Zydus Life Sciences’ Biosimilar Nivolumab Approved in India

Jul 7, 2024

On 7 July 2024, Medical Dialogues reported that Zydus Life Sciences’ biosimilar nivolumab has received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  The SEC has also conditionally approved Zydus’ biosimilar for all other approved indications of BMS’s Opdivo® (nivolumab) in India, subject to Zydus conducting a Phase IV study for those indications. 

In September 2020, NeuClone Pharmaceuticals disclosed that it was working on a nivolumab biosimilar, with the product being developed in partnership with the Serum Institute of India.