On 12 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has requested Alkem subsidiary, Enzene Biosciences, to revise its proposed Phase III clinical trial protocol for biosimilar nivolumab (injection 100mg/10mL vial).
According to the report, Enzene requested permission to conduct a multicentre, Phase III trial comparing its biosimilar nivolumab with BMS’ Opdivo® (nivolumab) in adults with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck, progressing on or after platinum-based therapy.
The SEC recommended a number of modifications to the protocol, including narrowing the non-inferiority margin used for sample size calculation and adding provisions for reporting safety data from the initial 20% of enrolled subjects. Enzene has been instructed to submit a revised protocol incorporating the changes recommended by the SEC.
At least one other nivolumab biosimilar has already received regulatory approval in India, with Zydus’ biosimilar approved in July 2024 for locally advanced or metastatic non-small cell lung cancer, and conditional approval for all other approved indications of BMS’ Opdivo®. Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.