On July 15, 2025, the FDA approved Biocon’s Kirsty™ (insulin aspart-xjhz) as the first interchangeable biosimilar of Novo Nordisk’s NovoLog® (insulin aspart). Biocon’s aBLA for Kirsty™ (formerly MYL-1601D) was pending since July 2020 and received Complete Response Letters in January 2022 and October 2023. Insulin aspart is a rapid acting human insulin analog that is FDA-approved to improve glycemic control in adults and pediatric patients with diabetes mellitus.
The first insulin aspart biosimilar, Sanofi’s Merilog™ / Merilog SoloStar® (insulin aspart-szjj), was approved in February 2025 (previously reported FDA Approves First NovoLog® (insulin aspart) Biosimilar: Sanofi’s Merilog™ / Merilog SoloStar®). Sandoz / Gan & Lee have a pending aBLA at the FDA for Rapilin™ (insulin aspart), accepted in June 2023. There are currently no related patent proceedings.
Novo Nordisk reported U.S. sales of approximately $1.06B USD (7.56B DKK) for NovoLog® (also referred to as NovoRapid®) in 2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
