Biocon Pharma Limited has received regulatory clearance from the Central Drugs Standard Control Organisation (CDSCO) for its liraglutide injection (6 mg/ml solution in a pre-filled pen and cartridge). This marks the approval of the generic version of Victoza, used to manage type 2 diabetes in adults, adolescents, and children aged 10 and above, alongside diet and exercise. The clearance was granted under the CDSCO’s newly introduced 101 route, which acknowledges authorizations by globally recognized regulatory bodies.

Siddharth Mittal, CEO and Managing Director of Biocon, emphasized that this development represents a key milestone in the company’s mission to improve access to affordable diabetes care in India. With over 77 million people in India affected by diabetes—a number expected to rise—this approval allows Biocon to serve a significant healthcare need.

The liraglutide product is Biocon’s first vertically integrated GLP-1 therapy approved in India and aligns with the company’s goal to provide cost-effective, life-saving medications. The launch of the drug will be carried out swiftly in partnership with local commercialization partners.

As GLP-1 therapies are anticipated to play a vital role in Biocon’s future growth, the company is committed to strengthening its leadership in the diabetes treatment landscape.