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Biocon Pharma, a subsidiary of Biocon, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Dapagliflozin Tablets, 5 mg and 10 mg.
The approved product is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, and reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
This approval further strengthens Biocon's expanding diabetes portfolio, which spans oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, reinforcing the Company's integrated approach to addressing the evolving needs of people living with diabetes globally.
Dapagliflozin Tablets will be manufactured at Biocon's FDA-approved facilities, in compliance with global quality and regulatory standards.
The approved product is indicated for the treatment of adults with type-2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, and reduce the risk of hospitalization for heart failure in adults with type-2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Dapagliflozin Tablets will be manufactured at Biocon’s FDA-approved facilities, in compliance with global quality and regulatory standards.
'This approval further strengthens Biocon’s expanding diabetes portfolio, which spans oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, reinforcing the company’s integrated approach to addressing the evolving needs of people living with diabetes globally,” the Bengaluru-based company said in a statement.
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
The company's consolidated net profit surged to Rs 143.80 crore in the quarter ended December 2025 as against Rs 25.10 crore during the previous quarter ended December 2024. Sales rose 9.28% to Rs 4,123 crore in Q3 FY26 as compared with Q3 FY25.
Biocon announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab kyqq) in the United States.
Bosaya™ (biosimilar to Prolia®) and Aukelso™ (biosimilar to Xgeva®) are now available by prescription nationwide through specialty pharmacies and healthcare providers.
Both products have been previously approved and granted interchangeable designation by the U.S. Food and Drug Administration in September 2025, allowing substitution at the pharmacy level in accordance with state laws.
Shreehas Tambe, CEO & Managing Director, Biocon, said, “The U.S. introduction of Bosaya™ and Aukelso™ marks a strategic expansion of our biosimilars portfolio, building on our established leadership in oncology and immunology. These therapies broaden access to high-quality, affordable treatment options for patients living with serious bone conditions. This milestone underscores Biocon's strength as a portfolio development engine and our focus on building the world's most scalable access platform—advancing life-changing medicines for patients and health systems across the United States and around the world.”
Biocon has received approval from the U.S. FDA, for its complex formulation Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens (gSaxenda®).
Liraglutide is a drug-device combination formulation used in the treatment of chronic weight management, indicated as an adjunct to a reduced-calorie diet and increased physical activity.
GLP-1 receptor agonists have emerged as one of the fastest growing therapeutic classes globally, driven by the rising prevalence of obesity and metabolic disorders, strong clinical outcomes, and increasing physician adoption.
According to IQVIA MAT December 2025 the total addressable market opportunity for GLP-1 in weight loss in the U.S. was US $127 million.
Siddharth Mittal, chief executive officer and managing director, Biocon, said: “This timely approval of gSaxenda in the United States marks a defining milestone for Biocon, validating our scientific depth, our vertically integrated development and manufacturing platform, and our ability to bring complex drug products to markets around the world.
GLP-1 therapies represent a significant growth driver for the company, with the U.S. being an important market in this strategy.”
The scrip rose 0.35% to currently trade at Rs 391.70 on the BSE.
Biocon Ltd is up for a fifth straight session today. The stock is quoting at Rs 394.6, up 0.99% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.31% on the day, quoting at 25504.3. The Sensex is at 82333.07, up 0.13%. Biocon Ltd has gained around 8.04% in last one month.
Meanwhile, Nifty Pharma index of which Biocon Ltd is a constituent, has gained around 5.55% in last one month and is currently quoting at 22632.05, up 1.62% on the day. The volume in the stock stood at 19.62 lakh shares today, compared to the daily average of 31.82 lakh shares in last one month.
The benchmark March futures contract for the stock is quoting at Rs 397.7, up 1.21% on the day. Biocon Ltd is up 26.54% in last one year as compared to a 13.13% jump in NIFTY and a 13.84% jump in the Nifty Pharma index.
The PE of the stock is 325.29 based on TTM earnings ending December 25.
Biocon Ltd rose for a fifth straight session today. The stock is quoting at Rs 373.85, up 0.42% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.04% on the day, quoting at 25738.7. The Sensex is at 83674.2, down 0.08%. Biocon Ltd has dropped around 4.47% in last one month.
Meanwhile, Nifty Pharma index of which Biocon Ltd is a constituent, has dropped around 2.45% in last one month and is currently quoting at 22200.25, down 0.07% on the day. The volume in the stock stood at 7.52 lakh shares today, compared to the daily average of 33.42 lakh shares in last one month.
The benchmark February futures contract for the stock is quoting at Rs 375.75, up 0.51% on the day. Biocon Ltd is down 4.2% in last one year as compared to a 8.62% gain in NIFTY and a 1.45% gain in the Nifty Pharma index.
The PE of the stock is 0 based on TTM earnings ending September 25.
Biocon Ltd is up for a third straight session today. The stock is quoting at Rs 383.95, up 1.31% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.35% on the day, quoting at 25755.6. The Sensex is at 83702.57, up 0.38%. Biocon Ltd has slipped around 0.56% in last one month.
Meanwhile, Nifty Pharma index of which Biocon Ltd is a constituent, has slipped around 1.33% in last one month and is currently quoting at 22505.4, down 0.86% on the day. The volume in the stock stood at 17.89 lakh shares today, compared to the daily average of 26.3 lakh shares in last one month.
The benchmark January futures contract for the stock is quoting at Rs 384.45, up 1.33% on the day. Biocon Ltd is down 2.48% in last one year as compared to a 11% jump in NIFTY and a 1.13% jump in the Nifty Pharma index.
Biocon announced the successful completion of a Qualified Institutions Placement (QIP), raising Rs 4,150 crore (~USD 460 million) through the issuance of 112,664,585 equity shares of face value Rs 5 each to eligible qualified institutional buyers at the issue price of Rs 368.35 per equity share (including a premium of Rs 363.35 per equity share).
The QIP, which opened on 12 January 2026, and closed on 14 January 2026, attracted strong investor interest from a broad mix of domestic and international participants, reflecting robust confidence in Biocon's growth prospects.
The proceeds from the QIP will be primarily utilized to meet the cash consideration payable to Mylan Inc. (Viatris) for buying out its shareholding in Biocon Biologics, including repayment of debt availed in this regard. Biocon recently announced that its Board of Directors had approved a strategic corporate action to acquire all remaining minority shareholdings, including Viatris' stake, thereby making Biocon Biologics a wholly owned subsidiary of the Company.