Biocon Biologics Expands Diabetes Portfolio with FDA Approval of Kirsty™, the First and Only Interchangeable Rapid-Acting Insulin Aspart in the United States

Biocon Biologics Ltd (BBL) has announced that the U.S. 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 analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. 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. Biocon Biologics is a global leader in biosimilars and insulin production and is among the top three global players for rh- Insulin and Insulin Glargine, providing over 9.2 billion doses of insulin globally with a broad portfolio comprising basal, mixed and rapid acting insulins.