Biocon Biologics expands diabetes portfolio with FDA approval for Kirsty

Interchangeable biosimilar to NovoLog in the US and will be available in prefilled pens and vials

Biocon Biologics, a subsidiary of biopharmaceutical company Biocon, said on Wednesday that the US Food and Drug Administration (FDA) has approved Kirsty (Insulin Aspart), the “first and only” interchangeable biosimilar to NovoLog (Insulin Aspart).

 

Kirsty is a rapid-acting human insulin for improving glycaemic control in adults and paediatric patients with diabetes mellitus. It will be available as a single-patient-use prefilled pen for subcutaneous administration and as a multi-dose vial for both subcutaneous and intravenous use. (An interchangeable biosimilar can be swapped for its original biologic at the pharmacy without prescriber approval.)

 

“The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the US, is a significant step forward in our efforts to make insulin more accessible and affordable,” said Shreehas Tambe, chief executive officer and managing director of Biocon Biologics. 

 

 

“It builds on the foundation we laid with Semglee, reinforcing our commitment to scientific excellence and patient-centric innovation. With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care,” he said.

 

The approval for Kirsty strengthens Biocon Biologics’ biosimilar insulin portfolio, which includes Semglee Insulin, the first FDA-approved interchangeable biosimilar. Kirsty has been available in Europe and Canada since 2022.

 

Biocon Biologics in March announced a strategic collaboration with Civica Inc. to improve access and affordability of Insulin Aspart in the US. The company has also previously received US FDA approvals for biosimilars, including Ogivri (biosimilar Trastuzumab), Fulphila (Pegfilgrastim), and Semglee (Insulin Glargine).

 

 

 

Biocon Biologics said it serves over 5.8 million patients annually globally and offers a comprehensive portfolio of approved and pipeline biosimilars across multiple therapeutic areas. This includes eight biosimilars in the US and seven in Canada

 

An estimated 38.4 million people in the US, around 11.6 per cent of the population, live with diabetes, with nearly a quarter remaining undiagnosed. Additionally, 97.6 million Americans have been identified as pre-diabetic. According to IQVIA, the US sales of Insulin Aspart reached approximately $1.9 billion in 2024.