KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use
Biocon Biologics announced that the US Food and Drug Administration (FDA) has approved Kirsty (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). KIRSTY is a rapid-acting human insulin analogue indicated to improve glycemic control in adults and paediatric patients with diabetes mellitus. KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.
The FDA approval of KIRSTY expands Biocon Biologics’ biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection). KIRSTY has been available in Europe and Canada since 2022.
Shreehas Tambe, CEO and MD, Biocon Biologics, said, “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. 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.”
