Biocon Limited has informed the Exchange regarding a press release dated July 15, 2025, titled "Biocon Biologics Expands Diabetes Portfolio with FDA Approvalof Kirsty , the First and Only Interchangeable Rapid-ActingInsulin Aspart in the United States".
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Biocon's subsidiary Biocon Biologics has received USFDA approval for Kirsty (Insulin Aspart-xjhz), the first and only interchangeable biosimilar to NovoLog in the United States. Kirsty is a rapid-acting insulin for adults and pediatric patients with diabetes, available as a prefilled pen and multiple-dose vial. The product was already selling in Europe and Canada since 2022. The US Insulin Aspart market was approximately $1.9 billion in 2024, with 38.4 million Americans living with diabetes. This strengthens Biocon Biologics' position as a top-3 global insulin player and expands its biosimilar portfolio alongside Semglee (Insulin Glargine).
Positive for Biocon shareholders - unlocks access to a sizeable $1.9 billion US market with a first-mover interchangeable status, likely driving future revenue growth in the biosimilars segment. May support a positive short-term sentiment on the stock given the regulatory milestone.