Biocon Limited, a global biopharmaceutical company, has announced that it has received regulatory approval in India for its Liraglutide drug substance. Its wholly owned subsidiary, Biocon Pharma Limited, has also secured approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge) from the Central Drugs Standard Control Organisation (CDSCO).
The product is a generic version of Victoza®, used as an adjunct to diet and exercise to improve glycemic control in adults, adolescents, and children aged 10 years and older with Type 2 Diabetes Mellitus that is not adequately managed.
Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, commented, “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’’
This approval was granted under the CDSCO’s recently introduced 101 route. This regulatory pathway allows for the recognition of approvals issued by referenced and established foreign regulatory agencies, thereby facilitating faster access to critical medicines in India.
Glucagon-like peptide-1 (GLP-1) therapies, including Liraglutide, are being recognized as a growing segment in diabetes management. Biocon has stated its intent to expand its portfolio in this category as part of its future business strategy.
