Biocon shares gained 3% in early trade today after its subsidiary, Biocon Biologics Ltd (BBL), received significant approval from the USFDA. The regulator has greenlit Kirsty™ (Insulin Aspart-xjhz) as the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) in the United States. As of 9:15 AM, the shares were trading 3.21% higher at Rs 403.00.
This approval is a big win for the company as KIRSTY becomes part of BBL’s growing global biosimilar insulin portfolio. It will be available in two forms — a prefilled pen for subcutaneous use and a multiple-dose vial for both subcutaneous and intravenous use. The product is designed to help manage blood sugar levels in adults and children with diabetes.
This latest nod adds to Biocon Biologics’ impressive track record, which already includes Semglee® (Insulin Glargine), the first-ever interchangeable biosimilar approved in the U.S. KIRSTY is already being sold in Europe and Canada since 2022.
With over 38 million people living with diabetes in the U.S. — and another 97 million at risk — the market for insulin therapies is enormous. In fact, Insulin Aspart sales in the U.S. were pegged at nearly $1.9 billion in 2024, as per IQVIA data.
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