On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.
Biocon’s liraglutide, the generic version of Novo Nordisk’s Victoza®, is indicated for the treatment of insufficiently controlled Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. The CDSCO approved Biocon’s liraglutide under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.
Biocon’s liraglutide was the first generic to Victoza® to be approved in the UK in March 2024, and was subsequently launched in February 2025. In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union. The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024. Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.