Bengaluru, Karnataka, India. June 2, 2025
Biocon Limited (BSE code: 532523, NSE: BIOCON), 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.
About Glucagon-like peptide-1 (GLP-1): Glucagon-like peptide-1 (GLP-1) are medications that help lower blood sugar levels and promote weight loss. They are physiological hormones that have multiple actions on glucose, mediated by the GLP-1 receptors released from gut enteroendocrine cells and control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion. GLP-1 also inhibits gastric emptying and food intake actions, maximizing nutrient absorption while limiting weight gain.
About Liraglutide: Liraglutide is a synthetic analog of GLP-1 peptide and is administered as a once-daily injection. It was approved for medical use in the European Union in 2009, and in the United States in 2010. Liraglutide was approved by the US FDA in 2014, and by the EMA a year later, for adults who are either obese or overweight with atleast one weight-related condition. In 2019, it was approved by the US FDA for the treatment of children who are ten years or older with type 2 diabetes, making it the first non-insulin drug approved to treat type 2 diabetes in children since metformin was approved in 2000.
About Biocon Limited: Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceutical company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the U.S. and Europe. It also has a pipeline of promising novel assets in immunotherapy under development. www.biocon.com
Disclaimer: This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any forward- looking statement contained in this release.
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