Biocon's Kirsty™ Secures FDA Approval as First Interchangeable Rapid-Acting Insulin Aspart in US
Biocon Ltd's subsidiary, Biocon Biologics Ltd, has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), the first interchangeable biosimilar to NovoLog® in the US. Kirsty™, a rapid-acting human insulin analog for diabetes treatment, will be available in prefilled pens and multiple-dose vials. The approval expands Biocon's biosimilar insulin portfolio, which includes Semglee®. With 38.4 million diabetics in the US, this approval aims to improve insulin accessibility and affordability. Analysts project annual sales of $80-100 million post-formulary addition for Kirsty™.

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Biocon Ltd , a leading biopharmaceuticals company, has achieved a significant milestone in its diabetes care portfolio. The U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), marking it as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) in the United States.
Key Highlights
- Kirsty™ is a rapid-acting human insulin analog for diabetes treatment.
- It's the first interchangeable biosimilar to NovoLog® in the US market.
- The drug is already available in the European Union and Canada.
- Analysts project annual sales of $80-100 million post-formulary addition.
Expanding Diabetes Care Portfolio
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, announced that Kirsty™ has been approved as a 100 units/mL formulation. This approval expands Biocon's biosimilar insulin portfolio, which already includes Semglee® (Insulin Glargine-yfgn Injection), another FDA-approved interchangeable biosimilar.
Availability and Usage
Kirsty™ will be available in two forms:
- Single-patient-use prefilled pen for subcutaneous use
- Multiple-dose vial for both subcutaneous and intravenous use
The drug is indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus.
Market Impact
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., emphasized the significance of this approval: "The FDA approval of Kirsty™ is a significant step forward in our efforts to make insulin more accessible and affordable. It builds on the foundation we laid with Semglee®, reinforcing our commitment to scientific excellence and patient-centric innovation."
With 38.4 million people living with diabetes in the United States, representing approximately 11.6% of the total population, the need for affordable insulin options is crucial. The U.S. market for Insulin Aspart was valued at approximately $1.9 billion, according to IQVIA data.
Biocon's Position in the Global Insulin Market
Biocon Biologics has established itself as a global leader in biosimilars and insulin production:
- Among the top three global players for rh-Insulin and Insulin Glargine
- Provides over 9.2 billion doses of insulin globally
- Serves more than 5.8 million patients annually
- Has a comprehensive portfolio of in-market and in-development biosimilar products
This latest approval further solidifies Biocon's position in the diabetes care market and demonstrates its commitment to providing affordable, high-quality treatment options for patients worldwide.
Safety Information
As with all insulin products, healthcare providers and patients should be aware of potential risks, including hypoglycemia, hyperglycemia, and allergic reactions. Biocon advises never to share Kirsty™ prefilled pens, needles, or syringes between patients, even if the needle is changed, to prevent the potential transmission of blood-borne pathogens.
The approval of Kirsty™ represents a significant advancement in diabetes care, offering patients in the United States a new, interchangeable option for rapid-acting insulin. As Biocon continues to expand its portfolio and global reach, it remains focused on its mission to improve accessibility and affordability of critical medications for chronic conditions like diabetes.
Historical Stock Returns for Biocon
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