Biocon subsidiary receives U.S. FDA approval for Liraglutide Injection ANDA

Biocon Limited announced that its wholly owned subsidiary Biocon Pharma Limited has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza®), used to treat Type 2 Diabetes Mellitus in patients aged 10 years and above.

Biocon Limited has announced a key regulatory milestone after its subsidiary Biocon Pharma Limited received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza®).

The approval enables the company to market the generic version of Victoza, a widely used injectable medication for the treatment of Type 2 Diabetes Mellitus, in the United States.

Product Details and Therapeutic Use

The approved product is designed as an injectable formulation used in diabetes management and will be available in single-patient-use prefilled pens.

Product Specifications

Parameter Details

Product Name Liraglutide Injection (gVictoza®)

Strength 18 mg / 3 mL (6 mg/mL)

Delivery Format Single-Patient-Use Prefilled Pens

Indication Treatment of Type 2 Diabetes Mellitus

Eligible Patients Adults, adolescents, and children aged 10+

Treatment Role Adjunct to diet and exercise

Liraglutide helps control blood sugar levels and is prescribed for patients whose diabetes is not adequately controlled through lifestyle measures alone.

Second Liraglutide Approval for Biocon

This development marks Biocon’s second regulatory approval for a Liraglutide-based product in recent weeks.

The company had previously secured approval for Liraglutide Injection (gSaxenda®) on February 24, 2026, further strengthening its presence in the GLP-1 injectable therapy segment, which is widely used for diabetes and metabolic disorder treatment.

These approvals highlight Biocon’s capability in developing complex injectable and biologic medicines, a core focus area for the biotechnology company.

Strategic Importance for Biocon

The approval is expected to enhance Biocon’s portfolio of vertically integrated complex drug products and expand its presence in the U.S. diabetes treatment market, one of the largest pharmaceutical markets globally.

The introduction of generic Liraglutide formulations may also improve patient access to cost-effective diabetes therapies, especially as demand for GLP-1 class medications continues to grow worldwide.

Regulatory Disclosure

Biocon disclosed the development to stock exchanges as part of its regulatory compliance requirements.

The filing was signed by Rajesh Umakant Shanoy, Company Secretary and Compliance Officer, and the company confirmed that detailed information regarding the approval has been made available on its official website.