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United News of India
11 hours ago
- Business
- United News of India
Biocon Pharma gets DCGI nod for diabetes drug liraglutide in India
New Delhi, June 3 (UNI) Biocon Pharma Limited, a biopharmaceutical firm, on Tuesday said that drug regulator, Drugs Controller General of India under the CDSCO (Central Drugs Standard Control Organisation) has given nod to its liraglutide drug for Indian market. 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. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, termed the approval for liraglutide, as a step forward in expanding access of this product to patients suffering from diabetes. '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.'' Liraglutide is administered as a once-daily injection and was approved by the US FDA in 2019 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, said the release. According to various reports, India has an estimated 77 million people above 18 years old living with diabetes (type 2) and nearly 25 million with pre-diabetes. It is the second-highest country in the world for diabetes prevalence after China. UNI AJ PRS
Deccan Herald
13 hours ago
- Business
- Deccan Herald
Biocon gets CDSCO nod for generic diabetes medication
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 company said in a regulatory filing.
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Business Standard
14 hours ago
- Business
- Business Standard
Biocon gets CDSCO approval for generic diabetes medication 'Liraglutide'
Biotech firm Biocon on Tuesday said it has received approval from the government authorities for a generic diabetes medication. The company has received approval for its Liraglutide drug substance and its wholly-owned subsidiary Biocon Pharma 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). 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 company said in a regulatory filing. "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," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated. Biocon shares were trading 0.81 per cent up at Rs 336.75 apiece on BSE. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Time of India
15 hours ago
- Business
- Time of India
Biocon gets CDSCO nod for generic diabetes medication
Biotech firm Biocon on Tuesday said it has received approval from the government authorities for a generic diabetes medication . The company has received approval for its Liraglutide drug substance and its wholly-owned subsidiary Biocon Pharma 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 ). 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 company said in a regulatory filing. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Descubra ofertas de voos imperdíveis Voos | Anúncios de Pesquisa Saiba Mais Undo "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," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. Live Events "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated. Biocon shares were trading 0.81 per cent up at Rs 336.75 apiece on BSE.
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Business Standard
18 hours ago
- Business
- Business Standard
Biocon share price pops 2% on CDSCO nod for diabetes drug; key details here
Biocon share price: Bengaluru-based biopharmaceutical company Biocon shares were in demand in a weak market on Tuesday, June 3, 2025, with the stock rising up to 1.85 per cent to hit an intraday high of 340.25 per share. However, at 11:00 AM, Biocon share price was trading 0.49 per cent higher at 335.70 per share. What is the reason behind the uptick in Biocon share price? Biocon's share price saw an uptick following key regulatory approvals in India for its Liraglutide drug. The company received approval from the Central Drugs Standard Control Organisation (CDSCO) for its Liraglutide drug substance, while its wholly owned subsidiary, Biocon Pharma, secured approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge). Liraglutide is a synthetic analog of the GLP-1 peptide and is administered as a once-daily injection. It is a generic version of Victoza and is indicated for the treatment of Type 2 Diabetes Mellitus in adults, adolescents, and children aged 10 years and older, as an adjunct to diet and exercise. The original formulation was approved in the EU in 2009 and in the US in 2010. The approvals were granted under the CDSCO's recently introduced 101 route, which recognises approvals from established global regulatory authorities, streamlining the approval process in India. Siddharth Mittal, chief executive officer and managing director, Biocon, 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 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 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,' Biocon said, in a statement. Biocon Q4 results Biocon reported a strong financial performance for the fourth quarter of FY25, with consolidated net profit surging 153 per cent year-on-year (Y-o-Y) to ₹344 crore, up from ₹136 crore in the same quarter last year. Profit before tax (PBT) rose 53 per cent Y-o-Y to ₹487 crore. The company's Board also approved plans to raise up to ₹4,500 crore through various funding options, including qualified institutional placement (QIP), rights issue, or other permissible methods. The robust growth was driven by solid performance across its generics, biologics, and research services segments. Total consolidated revenue for the quarter stood at ₹4,454 crore, compared to ₹3,966 crore in Q4 FY24. Ebitda rose 16 per cent to ₹1,115 crore, with the margin maintained at 25 per cent. READ MORE About Biocon Biocon is a global biopharmaceutical company focused on developing and supplying affordable therapies for chronic diseases such as diabetes, cancer, and autoimmune disorders. The company manufactures and markets novel biologics, biosimilars, complex small molecule APIs, and generic formulations across India, the US, Europe, and other key markets. It is also advancing a pipeline of novel immunotherapy assets.
