Business
Biocon Biologics Expands Diabetes Portfolio with FDA Approval of Kirsty™, the First and Only Interchangeable Rapid-Acting Insulin Aspart in the United States
BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India, July 15, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today 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 im
About this update from Biocon Limited
[{"type":"text","content":"BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India, July 15, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today 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. KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.","length":726,"tagName":"p"},{"type":"text","content":"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.","length":252,"tagName":"p"},{"type":"text","content":"Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: “The FDA approval of Kirsty™, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., 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.”","length":593,"tagName":"p"},{"type":"text","content":"There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter of them being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA.","length":347,"tagName":"p"},{"type":"text","content":"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 portfoli...