Biocon Limited (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceutical company, announced that it has received approval in India for its Liraglutide drug substance.
Its wholly owned subsidiary, Biocon Pharma Limited, has received approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge) from the Drugs Controller General of India (DCGI), CDSCO.
The approval is for the generic version of Victoza®, 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.
This approval was granted under CDSCO’s recently formulated 101 route, which allows recognition of approvals granted by referenced serious regulatory authorities.
“The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access to this product for patients with diabetes.
India has one of the highest numbers 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 and aligns with Biocon’s mission to provide affordable, lifesaving medications to those who need them the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India.”
Biocon sees GLP-1 therapies as a substantive future growth driver and is committed to strengthening its presence in this therapeutic area.
Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss. These physiological hormones act on GLP-1 receptors and control meal-related glycemic excursions by enhancing insulin secretion and suppressing glucagon release.
GLP-1 also delays gastric emptying, reduces food intake, and improves nutrient absorption while minimizing weight gain.
Liraglutide is a synthetic analog of GLP-1 peptide, administered as a once-daily injection. Key regulatory approvals include:
It was the first non-insulin drug approved for pediatric Type 2 Diabetes since metformin (2000).
Biocon Limited, publicly listed in 2004 (BSE: 532523, NSE: BIOCON, ISIN: INE376G01013), is an innovation-led global biopharmaceutical company. It is focused on affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
Biocon has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and global markets. It also manufactures generic formulations for the U.S. and Europe and maintains a robust pipeline of novel immunotherapy assets.
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