Kirsty
Insulin aspart biosimilar developed by Biocon Biologics (with Mylan / Viatris), development code MYL-1601D. Reference product NovoRapid (NovoLog in the United States).
Brands by market: Kirsty (USA, EU, UAE); previously Kixelle (EU) · Commercial partner or holder: Biocon Biologics
FDAJul 2025approved
EMAFeb 2021authorised
CDSCOnot listed
EDEJul 2023registered
Status by market
FDA
United States · Kirsty
US Food and Drug AdministrationApprovedBrand
Kirsty
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Jul 2025
Application or permission
761188
Licence type
351(k) interchangeable, designated Jul 2025
Presentations
100 units/mL, 3 mL pen and 10 mL vial
Note
First interchangeable insulin aspart.
Source
S001, S016
EMA
European Union · Kirsty
European Medicines Agency and European CommissionApprovedBrand
Kirsty
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Feb 2021
Application or permission
EMEA/H/C/004965
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 1 year
Presentations
see SmPC
Note
Authorised as Kixelle, renamed Kirsty.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Kirsty
Emirates Drug EstablishmentRegisteredBrand
Kirsty
Holder or applicant
Biocon Sdn. Bhd., Malaysia · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Jul 2023
Presentations
100 units/mL
Source
S018
Chronology
- EMAFeb 2021Authorised by the European Commission as Kirsty
- EDEJul 2023Registered in the UAE as Kirsty
- FDAJul 2025Approved by FDA as Kirsty
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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