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Biocon’s Generic Liraglutide Injection FDA Approved

Feb 24, 2026

On 24 February 2026, Biocon announced that its liraglutide, gSaxenda®, biosimilar to Novo Nordisk’s Victoza® (liraglutide), has been approved by the FDA.  gSaxenda® is a drug-device combination (6 mg/mL single-use pre-filled pen) approved for the treatment of chronic weight management as an adjunct to diet and exercise.

In June 2025, Biocon’s liraglutide received approval from India’s Central Drugs Standard Control Organisation (CDSCO) for the treatment of Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise.

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 EU.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.