Biocon’s Kirsty Makes History: First Interchangeable Insulin Aspart in America

Biocon Biologics Ltd. achieved another key regulatory milestone with the U.S. FDA approval of Kirsty (Insulin Aspart-xjhz), the first and only biosimilar interchangeable of NovoLog in the U.S. market. The approval significantly strengthens Biocon's diabetes care business and reestablishes its biosimilar innovation leadership.

 

Key Highlights:

 

- Kirsty is a fast-acting human insulin analogue designed to improve glycemic control in children and adults with diabetes.

 

- It will be available in two forms: a one-patient-use prefilled pen for subcutaneous injection and a multiple-dose vial for intravenous or subcutaneous injection.

 

- FDA designation of Kirsty as interchangeable means it can be substituted with NovoLog without the need for prescriber intervention, a major move toward access and affordability.

 

- This clearance comes after Biocon's previous success with Semglee, the first interchangeable biosimilar insulin glargine.

 

- Kirsty has already been introduced in Canada and Europe as of 2022, and its introduction in the U.S. is targeting a market where the sales of Insulin Aspart totaled around $1.9 billion in 2024.

 

- It was approved on the basis of comprehensive analytical, nonclinical, and clinical information demonstrating no clinically significant differences from NovoLog in safety, efficacy, purity, and potency.

 

Market Impact & Vision:

 

Biocon Biologics is working towards increasing the therapeutic options for the 38.4 million Americans with diabetes, almost a quarter of whom remain undiagnosed. With Kirsty, the firm remains committed to enabling greater access to high-quality insulin therapies for more people worldwide.

 

Sources: Biocon Biologics, Drugs.com, CNBC TV18, Drug Development & Delivery.