Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon announced that the US Food and Drug Administration (FDA) has approved Kirsty (Insulin Aspart-xjhz), 100 units/mL as an interchangeable* biosimilar to NovoLog (Insulin Aspart). KIRSTY is a rapid-acting human insulin analogue indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. KIRSTY will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.
The FDA approval of KIRSTY expands Biocon Biologics’ biosimilar insulin portfolio, which also includes the first approved interchangeable biosimilar, Semglee (Insulin Glargine-yfgn Injection). KIRSTY has been available in Europe and Canada since 2022.
There are 38.4 million people with diabetes in the United States, approximately 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. Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA.
* 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) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of KIRSTY has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
- Malfunction: Monitor glucose and administer KIRSTY by subcutaneous injection if pump malfunction occurs.