U.S. License Holder:
Viatris / Biocon
Date of License:
aBLA accepted by FDA 2021, Complete Response Letter January-2022
MYL-1601D (insulin aspart) is not FDA-approved. An aBLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Kirsty (BGP Pharma (Viatris)) (October-2021)
Biosimilars Approved In The E.U.
Kirsty (previously Kixelle) (Viatris / Biocon) (February-2021)