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Shares of Biocon Ltd. surged over 3% on Wednesday after its subsidiary, Biocon Biologics, received approval from the U.S. Food and Drug Administration (FDA) for its new diabetes drug, Kirsty (Insulin Aspart). Kirsty is now the first and only interchangeable biosimilar to NovoLog (Insulin Aspart) available in the United States, signifying a pivotal moment for Biocon Biologics’ global ambitions in diabetes care.
Kirsty is a rapid-acting human insulin analogue designed to improve glycemic control in both adult and pediatric patients with diabetes mellitus. The product will be available in two formats: a single-patient-use prefilled pen for subcutaneous injection, and a multiple-dose vial suitable for both subcutaneous and intravenous use.
This FDA approval notably expands Biocon Biologics’ U.S. portfolio, which already boasts Semglee (Insulin Glargine-vfgn Injection) as the first approved interchangeable biosimilar—a product available in Europe and Canada since 2022. Kirsty has also been marketed in the EU and Canada since 2022, but the U.S. FDA’s approval marks an important step in enhancing access for American patients.
With the U.S. facing a diabetes epidemic—38.4 million diagnosed individuals, plus nearly 100 million Americans identified as prediabetic—the arrival of an interchangeable insulin biosimilar is expected to create more competition and potentially lower costs for patients. The U.S. market for Insulin Aspart itself accounted for about $1.9 billion in sales in 2024.
Biocon Biologics supplies over 9.2 billion insulin doses globally every year and serves more than 5.8 million patients annually through a diverse range of biosimilar products. With Kirsty’s approval, Biocon strengthens its position among the world’s top three insulin producers and advances its mission to make diabetes treatments more affordable and available worldwide.
The announcement prompted a positive response from investors, with Biocon shares climbing to a 52-week high of Rs 405.9 and closing at Rs 390.20 on the BSE—a 3% gain for the day.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, commented: “The FDA approval of Kirsty, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the US, is a significant step forward in our efforts to make insulin more accessible and affordable. 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.”
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