Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL, marking it as the first and only interchangeable biosimilar* to NovoLog® (Insulin Aspart).
Kirsty™ is a rapid-acting human insulin analog approved to improve glycemic control in adults and children with diabetes mellitus. It will be made available in two formats: a single-patient-use prefilled pen for subcutaneous injection and a multiple-dose vial suitable for both subcutaneous and intravenous administration.
This FDA approval expands Biocon Biologics’ insulin biosimilar portfolio, which already includes Semglee® (Insulin Glargine-yfgn)—the first interchangeable biosimilar insulin approved in the U.S. Kirsty™ has been available in Europe and Canada since 2022.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., stated:
“The FDA’s approval of Kirsty™, the first and only interchangeable biosimilar of rapid-acting Insulin Aspart in the U.S., marks another major milestone in our mission to enhance insulin accessibility and affordability. Building on the foundation established by Semglee®, this approval underscores our commitment to innovation that centers on patient needs. Kirsty™ broadens treatment options for people living with diabetes and furthers our ambition to become a global leader in diabetes care.”
According to the CDC, 38.4 million Americans—about 11.6% of the U.S. population—live with diabetes, nearly a quarter of whom remain undiagnosed. Another 97.6 million individuals are classified as prediabetic. In 2024, Insulin Aspart generated approximately $1.9 billion in U.S. sales, based on IQVIA data.
Biocon Biologics ranks among the world’s top three producers of rh-Insulin and Insulin Glargine, having delivered over 9.2 billion doses globally. Its extensive insulin portfolio includes basal, mixed, and rapid-acting insulins, reinforcing its leadership in diabetes care.
The company has achieved several notable industry “firsts,” including the U.S. approvals of biosimilar Trastuzumab (Ogivri®), Pegfilgrastim (Fulphila™), and Insulin Glargine (Semglee®). Globally, Biocon Biologics serves over 5.8 million patients annually, offering a growing portfolio of biosimilars across multiple therapeutic areas. The company has eight biosimilars approved in the U.S. and seven in Canada, with a pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies.