Biocon arm gets USFDA approval for insulin, Kirsty

Biocon announced that its subsidiary, Biocon Biologics, has received US Food and Drug Administration (USFDA) approval for Kirsty (Insulin Aspart-xjhz) 100 units/ml, to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Kirsty is biosimiler to Novolog. It is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It 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.

According to IQVIA, 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. Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024.

Shreehas Tambe, CEO & managing director, Biocon Biologics, 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.

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases.

The companys consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24.

The counter jumped 2.90% to settle at Rs 390.20 on the BSE.

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