Kirsty has been available in Europe and Canada since 2022. Photocredit: Dhiraj Singh
Biocon Biologics said on Wednesday that it received approval from the American health ruler to market a diabetes treatment medication.
The company, a unit of Biocon LTD, has received approval from the US Food and Drug Administration (USFDA) for Kirsty as the first and only interchangeable Biosimilar from Novolog (Insulin Aspart).
Kirsty is a fast-working human insulin analog that is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
The drug will be available as a pre -filled pen for a single patient for subcutaneous use and a bottle with multiple doses for subcutaneous and intravenous use, Biocon said in a statement.
The approval expands the biosimilar insulin portfolio of biocon biologics, which also includes the interchangeable biosimilar, Semglee (insulin Glargine-Yfgn injection).
An interchangeable product (IP) is an organic product that has been approved on the basis of data that shows that it is very similar to a reference product (RP) approved by the FDA.
Kirsty has been available in Europe and Canada since 2022.
According to the company, there are 38.4 million people with diabetes in the US, about 11.6 percent of the total population, almost a quarter of them are not diagnosed.
Another 97.6 million Americans have been identified as prediabetically, it added.
According to Iqvia, the sale of insulin Aspart in the US was around USD 1.9 billion in 2024.
Biocon shares traded 1.44 percent higher on RS 395.80 each on the BSE.
Published on July 16, 2025
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