Biocon Biologics gets FDA nod for first interchangeable rapid-acting insulin in U.S.

India, July 16 -- Biocon Biologics Ltd. (BBL), a global biosimilars company and a subsidiary of Biocon Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved Kirsty™ (Insulin Aspart-xjhz), 100 units/mL. This approval makes Kirsty™ the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) available in the United States.

Kirsty™, a rapid-acting human insulin analog, is approved to improve glycemic control in both adult and pediatric patients with diabetes mellitus. It will be offered as a single-patient-use prefilled pen for subcutaneous administration and a multiple-dose vial for both subcutaneous and intravenous use.

This FDA approval significantly strengthens Biocon Biologi...