Biocon Limited announced it has received regulatory approval in India for its generic version of liraglutide, marking a significant milestone in the company's expansion into the rapidly growing GLP-1 diabetes treatment market. The approval from India's Central Drugs Standard Control Organisation (CDSCO) covers both the drug substance and the formulated product, positioning Biocon to address the substantial diabetes burden in the country.
Regulatory Approval Details
The CDSCO granted approval for Biocon's liraglutide drug substance, while the company's wholly owned subsidiary, Biocon Pharma Limited, received clearance for the drug product formulated as a 6 mg/ml solution for injection in pre-filled pens and cartridges. The approval was obtained under the recently introduced 101 route, which enables faster approval based on prior clearances from globally recognized regulatory authorities.
The generic version of Novo Nordisk's Victoza is indicated for treating insufficiently controlled Type 2 diabetes mellitus in adults, adolescents, and children aged 10 years and above, as an adjunct to diet and exercise.
Addressing India's Diabetes Crisis
"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," said Siddharth Mittal, Chief Executive Officer and Managing Director of Biocon Ltd. "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 Biocon to address what Mittal described as "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."
GLP-1 Mechanism and Clinical Benefits
Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss through multiple physiological mechanisms. These hormones have multiple actions on glucose, mediated by GLP-1 receptors released from gut enteroendocrine cells. They control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion, while also inhibiting gastric emptying and food intake actions to maximize nutrient absorption while limiting weight gain.
Liraglutide, a synthetic analog of GLP-1 peptide, is administered as a once-daily injection. The drug was first approved for medical use in the European Union in 2009 and in the United States in 2010. Notably, in 2019, liraglutide received US FDA approval for treating children aged ten years or older with type 2 diabetes, making it the first non-insulin drug approved for pediatric type 2 diabetes treatment since metformin's approval in 2000.
Strategic Market Position
Biocon is positioning GLP-1 therapies as a substantive future growth driver, with the company committed to reinforcing its position as a key player in this therapeutic area. The company is now preparing to launch the product expeditiously through commercialization partners in India.
The regulatory approval represents Biocon's continued expansion in complex therapeutic areas, building on its established presence in biologics, biosimilars, and complex small molecule APIs across India and key global markets.
