Biocon Biologics Ltd (BBL) achieved a pivotal milestone in diabetes management with the U.S. FDA approval of Kirsty™ (Insulin Aspart-xjhz), 100 units/mL. This significant decision establishes Kirsty™ as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) in the United States, offering a crucial new option for patients. Kirsty™ is a rapid-acting human insulin analog, specifically indicated to improve blood sugar control in both adults and pediatric patients diagnosed with diabetes mellitus. To ensure broad accessibility and convenience, it will be available in both single-patient-use prefilled pens for subcutaneous injection and multiple-dose vials suitable for both subcutaneous and intravenous administration.

This landmark approval significantly expands Biocon Biologics’ already robust biosimilar insulin portfolio, building on the success of Semglee® (Insulin Glargine-yfgn Injection), which was the first approved interchangeable biosimilar insulin. With Kirsty™ already having a strong presence and proven track record in Europe and Canada since 2022, its introduction to the U.S. market is poised to make a substantial impact. Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., underscored the importance of this approval, noting it's a "significant step forward" in making insulin "more accessible and affordable." He emphasized that Kirsty™ will broaden treatment choices for the millions of Americans living with diabetes, reinforcing the company's commitment to scientific excellence and patient-centric innovation.

The need for more accessible insulin options in the U.S. is immense, with 38.4 million people living with diabetes and an additional 97.6 million identified as prediabetic. The market for Insulin Aspart alone was substantial, with sales reaching approximately $1.9 billion in 2024. As a global leader in biosimilars and insulin production, Biocon Biologics is uniquely positioned to address this demand. The company is among the top three global players for rh-Insulin and Insulin Glargine, having supplied over 9.2 billion doses of insulin worldwide through its comprehensive portfolio of basal, mixed, and rapid-acting insulins.

Biocon Biologics has a distinguished history of achieving industry "firsts" in the biosimilars space, including the initial FDA approvals for biosimilar Trastuzumab (Ogivri®), Fulphila™ (bPegfilgrastim), and Semglee® (bInsulin Glargine) in the United States. Serving over 5.8 million patients annually across 120+ countries, the company boasts a comprehensive pipeline of 20 biosimilar assets covering various therapeutic areas, including oncology, immunology, and ophthalmology, in addition to its strong diabetology focus. The approval of Kirsty™ further solidifies Biocon Biologics' commitment to transforming healthcare by delivering high-quality, affordable biosimilar medicines globally.