On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.
Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple dose vial for subcutaneous and intravenous use. It is indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus. Kirsty™ has been available in Europe and Canada since 2022.
In February 2025, Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were approved as the first US biosimilars to NovoLog®. However, those products have not been granted interchangeability status. There were also two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).