Biocon has announced that it has received approval from the Drugs Controller General of India (DCGI), under the Central Drugs Standard Control Organisation (CDSCO), for its Liraglutide drug substance.
In addition, Biocon’s wholly owned subsidiary, Biocon Pharma, has also obtained CDSCO approval for the Liraglutide drug product—a 6 mg/ml solution for injection available in pre-filled pens and cartridges. This approval pertains to the generic version of Victoza, indicated for the treatment of type 2 diabetes mellitus in adults, adolescents, and children aged 10 and above who have not achieved adequate glycemic control with diet and exercise alone. The approval was granted under the recently introduced 101 route, which facilitates recognition of approvals from established global regulatory authorities.
Siddharth Mittal, CEO and Managing Director of Biocon, stated, “The approval of our first vertically integrated GLP-1 product in India, Liraglutide, marks an important milestone in enhancing patient access to diabetes care. With over 77 million people in India living with diabetes—a number that is expected to rise—this approval allows us to meet a critical healthcare need. It also aligns with Biocon’s mission of delivering affordable, life-saving medications to those who need them most. We are now preparing to launch the product swiftly through our commercial partners in India.”
Biocon is a global, innovation-driven biopharmaceutical company committed to expanding access to affordable therapies for chronic conditions such as diabetes, cancer, and autoimmune disorders. The company has developed and commercialized a wide portfolio of novel biologics, biosimilars, complex small molecule APIs, and generic formulations across India, the U.S., Europe, and other key global markets.