Biocon Strengthens U.S. Diabetes Portfolio With FDA Approval For Rapid-Acting Insulin Kirsty™

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), marking it as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) in the U.S. This rapid-acting insulin analog is designed to help manage blood glucose levels in adults and children with diabetes. Kirsty will be offered in both a prefilled pen and a multiple-dose vial for subcutaneous and intravenous use.

This approval further strengthens Biocon Biologics’ position in the insulin space, adding to its previous milestone with Semglee® (Insulin Glargine-yfgn), the first FDA-approved interchangeable insulin biosimilar. Kirsty has already been available in Europe and Canada since 2022. In the U.S., where 38.4 million people are affected by diabetes, the approval represents a significant step toward increasing access to cost-effective treatment options. In 2024 alone, Insulin Aspart sales in the U.S. were approximately $1.9 billion.

“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,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd.

Biocon Biologics has a strong international presence, various doses of insulin manufactured over 9.2 billion worldwide and serves more than 5.8 million patients every year. The Biosimilars portfolio comprises 20 assets in monoclonal antibodies and insulins, and this makes the company one of the leading players globally in the Biosimilars business with multiple approvals in the U.S and Canada, like Ogivri® and Fulphila™.