On February 14, 2025, the FDA approved Sanofi’s Merilog™ / Merilog SoloStar® (insulin aspart-szjj), the first biosimilar of Novo Nordisk’s NovoLog® (insulin aspart). Merilog™ is packaged in a multi-dose vial, and Merilog SoloStar® is a prefilled pen. Viatris and Biocon have a pending aBLA at the FDA for MYL-1601D since at least 2021, and have received Complete Response Letters from the FDA in January 2022 and October 2023. There are no other publicly announced aBLAs for NovoLog® biosimilars, and 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.
_____________________________________________________
The author would like to thank April Breyer Menon for her contributions to this article.
