Biocon Biologics has secured the US Food and Drug Administration (FDA) approval for Kirsty, as the first interchangeable rapid-acting insulin aspart biosimilar in the US.
Kirsty, a rapid-acting human insulin analogue, is designed to enhance glycaemic control in adults and children with diabetes mellitus.
Biocon Biologics will offer Kirsty in two forms: a single-patient-use prefilled pen for subcutaneous administration and a multiple-dose vial for both subcutaneous and intravenous use.
The FDA approval is based on analytical, nonclinical, and clinical data that confirmed Kirsty’s similarity to NovoLog, with no significant differences in safety, efficacy, purity, or potency.
It broadens Biocon Biologics’ biosimilar insulin portfolio, which already includes Semglee, the first approved interchangeable biosimilar insulin glargine injection.
Kirsty has been available in Canada and Europe since 2022.
Biocon Biologics specialises in biosimilars and insulin production and is the first to receive US approval for biosimilar Trastuzumab, Ogivri, along with Fulphila and Semglee.
An interchangeable product is a biological product that is highly similar to an FDA-approved reference product, ensuring no clinically meaningful differences.
It can be expected to produce the same clinical result as the reference product in any patient, with no increased risk from alternating or switching between the two.
Biocon Biologics CEO and managing director Shreehas Tambe said: “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.
“It builds on the foundation we laid with Semglee, reinforcing our commitment to scientific excellence and patient-centric innovation.
“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.”
Recently, Biocon Biologics received the European Commission (EC) marketing authorisation for its Denosumab biosimilars, Vevzuo and Evfraxy, in the European Union.
The biosimilars improve bone health and treat conditions like osteoporosis and bone loss.
The EC approval follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), granted on 25 April 2025.
