Biocon Limited, an innovation-led global biopharmaceutical company, announced today that it has received approval In India for its Liraglutide drug substance, and its wholly owned subsidiary, Biocon Pharma Limited, has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India, CDSCO (Central Drugs Standard Control Organisation).

The approval is for the generic version of Victoza, 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 approval was received from the CDSCO under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.

Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, said: “The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon’s mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India.’’

With GLP-1 therapies projected to be a substantive future growth driver for Biocon, the Company remains committed to reinforcing its position as a key player in this area.