Biocon Limited announced it has received approval from the U.S. FDA for its Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pens (gSaxenda®) for chronic weight management. The drug-device combination formulation is indicated as an adjunct to a reduced-calorie diet and increased physical activity for treating chronic weight management.

FDA Approval Details

The approval represents a significant regulatory milestone for Biocon's complex formulation capabilities. Liraglutide is a synthetic analog of GLP-1 peptide administered as a once-daily injection, originally approved for medical use in the European Union in 2009 and in the United States in 2010 for diabetes treatment.

Market Opportunity and Strategic Impact

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. GLP-1 receptor agonists have emerged as one of the fastest growing therapeutic classes globally, driven by rising prevalence of obesity and metabolic disorders, strong clinical outcomes, and increasing physician adoption.

Siddharth Mittal, Chief Executive Officer and Managing Director of Biocon Ltd, stated that this approval marks a defining milestone for the company, validating their scientific depth and vertically integrated development and manufacturing platform. He emphasized the company's commitment to commercializing Liraglutide at the earliest to ensure U.S. patients benefit from a high-quality, affordable treatment option.

About GLP-1 and Liraglutide

Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss. These physiological hormones have multiple actions on glucose, mediated by GLP-1 receptors released from gut enteroendocrine cells. They control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion, while also inhibiting gastric emptying and food intake actions.

Liraglutide was specifically approved by the U.S. FDA in 2014 for adults who are either obese or overweight with at least one weight-related condition. In 2019, it became the first non-insulin drug approved to treat type 2 diabetes in children since metformin was approved in 2000.

Company Profile

Biocon Limited, publicly listed in 2004, is an innovation-led global biopharmaceuticals company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. The company 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 US, Europe and key emerging markets.

Biocon Limited announced its unaudited financial results for the quarter and nine months ended December 31, 2025, revealing mixed performance with operational growth offset by significant exceptional items. The biotechnology major reported contrasting results between its standalone and consolidated operations during the third quarter of fiscal year 2026.

Q3FY26 Earnings Call Recording Available

Following its quarterly results announcement, Biocon Limited has shared the audio and video recording links for its Q3FY26 earnings call conducted on February 13, 2026. The company communicated this information to both BSE Limited and National Stock Exchange of India Limited under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Standalone Financial Performance

The company's standalone operations faced headwinds during Q3FY26, primarily due to exceptional items that significantly impacted profitability. Despite revenue growth, the bottom line was severely affected by one-time charges.

The company's revenue from operations grew by 10.4% year-on-year to ₹6,213 million in Q3FY26, demonstrating underlying business strength. However, exceptional items of ₹1,963 million turned what would have been a profit before tax of ₹1,118 million into a loss of ₹845 million before tax.

Consolidated Results Show Resilience

On a consolidated basis, Biocon's performance reflected the diversified nature of its business portfolio across generics, biosimilars, and contract research services.

The consolidated revenue from operations reached ₹41,730 million in Q3FY26, with the Generics segment showing particularly strong growth of 24.0% year-on-year. The Biosimilars segment, which remains the largest revenue contributor, grew by 9.1%, while the Contract Research, Development, and Manufacturing Organisation (CRDMO) segment experienced a slight decline of 2.8%.

Strategic Corporate Actions

The Board of Directors approved significant strategic initiatives during the quarter. Most notably, the company received in-principle approval to acquire the remaining approximately 2% stake in Biocon Biologics Limited from employees and other shareholders. This acquisition will be executed through preferential allotment of equity shares, making BBL a wholly owned subsidiary upon completion.

Regulatory Compliance and Transparency

The communication regarding the earnings call recording demonstrates Biocon's commitment to regulatory compliance and investor transparency. The recording is accessible through the company's investor relations section, providing stakeholders with comprehensive access to management discussions and strategic insights shared during the quarterly earnings call.