Biocon Limited — Updates, 16-07-2025: Press Release

Biocon Biologics received US FDA approval for Kirsty™ (Insulin Aspart-xjhz), the first and only interchangeable rapid-acting insulin aspart biosimilar. This significantly expands their diabetes portfolio in the critical US market. Kirsty aims to improve glycemic control in diabetes patients and will be available as a prefilled pen and vial. The US market for Insulin Aspart was approximately $1.9 billion in 2024, highlighting a substantial market opportunity. This approval reinforces Biocon's strategy to enhance insulin accessibility and affordability, building on their established portfolio including Semglee®. Kirsty has been available in Europe and Canada since 2022.