New Delhi: Biocon Biologics on Wednesday said it has received approval from the US health regulator 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 to NovoLog ( Insulin Aspart).
Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
The medication will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, Biocon said in a statement.
The approval expands Biocon Biologics' biosimilar insulin portfolio, which also includes the interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection).
An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP).
Kirsty has been available in Europe and Canada since 2022.
As per the company, there are 38.4 million people with diabetes in the US, around 11.6 per cent of the total population, with nearly a quarter of them being undiagnosed.
An additional 97.6 million Americans have been identified as prediabetic, it added.
According to IQVIA, sales of Insulin Aspart in the US stood around USD 1.9 billion in 2024.
Shares of Biocon were trading 1.44 per cent up at Rs 395.80 apiece on the BSE.
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 to NovoLog ( Insulin Aspart).
Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
The medication will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use, Biocon said in a statement.
The approval expands Biocon Biologics' biosimilar insulin portfolio, which also includes the interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection).
An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP).
Kirsty has been available in Europe and Canada since 2022.
As per the company, there are 38.4 million people with diabetes in the US, around 11.6 per cent of the total population, with nearly a quarter of them being undiagnosed.
An additional 97.6 million Americans have been identified as prediabetic, it added.
According to IQVIA, sales of Insulin Aspart in the US stood around USD 1.9 billion in 2024.
Shares of Biocon were trading 1.44 per cent up at Rs 395.80 apiece on the BSE.
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