Biocon's Kirsty™ Secures FDA Approval as First Interchangeable Rapid-Acting Insulin Aspart in US

2 min read     Updated on 16 Jul 2025, 07:21 AM
scanxBy ScanX News Team
whatsapptwittershare
Overview

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™.

14176277

*this image is generated using AI for illustrative purposes only.

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:

  1. Single-patient-use prefilled pen for subcutaneous use
  2. 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

1 Day5 Days1 Month6 Months1 Year5 Years
+1.08%+5.65%+10.47%+0.38%+11.67%-7.46%

Biocon Biologics Secures FDA Approval for Kirsty™, First Interchangeable Rapid-Acting Insulin Aspart in U.S.

1 min read     Updated on 16 Jul 2025, 07:07 AM
scanxBy ScanX News Team
whatsapptwittershare
Overview

Biocon Biologics, a Biocon Ltd subsidiary, has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), the first interchangeable biosimilar to NovoLog® in the US. Kirsty™ is a rapid-acting insulin for diabetes management in adults and children, available in prefilled pens and vials. This approval expands Biocon's biosimilar insulin portfolio in the US market, where 38.40 million people have diabetes. The US Insulin Aspart market is valued at approximately $1.90 billion. Biocon Biologics, a global leader in biosimilars and insulin, serves over 5.80 million patients annually with 9.20 billion insulin doses globally.

14175430

*this image is generated using AI for illustrative purposes only.

Biocon Biologics, a subsidiary of Biocon Ltd, has achieved a significant milestone in its diabetes care portfolio. The U.S. Food and Drug Administration (FDA) has granted approval for 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 glycemic control in adults and pediatric patients with diabetes mellitus.
  • The product will be available as a single-patient-use prefilled pen and a multiple-dose vial for subcutaneous and intravenous use.
  • This approval expands Biocon Biologics' biosimilar insulin portfolio in the U.S. market.

Market Impact

The approval of Kirsty™ is poised to make a significant impact on the U.S. diabetes care market:

  • There are 38.40 million people with diabetes in the United States, representing approximately 11.60% of the total population.
  • Sales of Insulin Aspart in the United States were approximately $1.90 billion, according to IQVIA.

Executive Commentary

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., stated, "The FDA approval of Kirsty™, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., 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."

Biocon Biologics' Position in the 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 9.20 billion doses of insulin globally
  • Serves over 5.80 million patients annually
  • Has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies

Safety Information

As with all insulin products, healthcare providers and patients should be aware of important safety information for Kirsty™:

  • Contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin aspart products.
  • Warnings include risks of hyperglycemia or hypoglycemia with changes in insulin regimen, medication errors, and hypersensitivity reactions.
  • Patients should never share Kirsty™ prefilled pens, needles, or syringes, even if the needle is changed.

This FDA approval represents a significant advancement in Biocon Biologics' mission to improve accessibility and affordability of diabetes care in the United States. As the first interchangeable rapid-acting insulin aspart in the U.S. market, Kirsty™ is set to provide more options for healthcare providers and patients managing diabetes.

Historical Stock Returns for Biocon

1 Day5 Days1 Month6 Months1 Year5 Years
+1.08%+5.65%+10.47%+0.38%+11.67%-7.46%
More News on Biocon
Explore Other Articles
TANFAC Industries Reports Robust Q1 Performance with Significant Revenue and Profit Growth 7 minutes ago
Manali Petro Boosts Production Capacity to 50,000 KTPA, Eyes ₹500 Crore Annual Revenue 1 hour ago
Mic Electronics Secures Railway Contract and Obtains BIS Certification 4 hours ago
394.65
+4.20
(+1.08%)