U.S. License Holder:
Novo Nordisk Inc.
Date of License:
NOVOLOG (insulin aspart recombinant) is a rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Accepted by FDA
MYL-1601D: Viatris / Biocon (2021, Complete Response Letter January-2022)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Kirsty (BGP Pharma (Viatris)) (October-2021)Trurapi (Sanofi) (February-2021)
Biosimilars Approved In The E.U.
Insulin Aspart Sanofi (Sanofi) (July-2020) Kirsty (previously Kixelle) (Viatris / Biocon) (February-2021)
Biosimilars Approved In Australia
Truvelog (Sanofi) (October-2020)