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

Core Insights - Biocon Biologics Ltd has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), marking it as the first and only interchangeable biosimilar to NovoLog® in the U.S. [1][2][3] - Kirsty™ is a rapid-acting human insulin analog aimed at improving glycemic control in both adults and pediatric patients with diabetes mellitus [1][3]. - The approval of Kirsty™ enhances Biocon Biologics' biosimilar insulin portfolio, which includes Semglee® (Insulin Glargine-yfgn Injection) [2][3]. Company Overview - Biocon Biologics is recognized as a global leader in biosimilars and insulin production, providing over 9.2 billion doses of insulin globally [4]. - The company has achieved several industry milestones, including the first approval of biosimilar Trastuzumab in the U.S. and has a comprehensive portfolio of 20 biosimilar assets across various therapy areas [5][11]. - Biocon Biologics serves over 5.8 million patients annually across more than 120 countries, focusing on affordable access to high-quality biosimilars [10][11]. Market Context - There are approximately 38.4 million people with diabetes in the U.S., representing about 11.6% of the total population, with nearly a quarter undiagnosed [3]. - The U.S. sales of Insulin Aspart were approximately $1.9 billion in 2024, indicating a significant market opportunity for Kirsty™ [3].