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 · Company profile

FDAJul 2025approved

EMAFeb 2021authorised

MHRALicenseddate not shown

PMDANot listed

HCOct 2021approved

CDSCONot listed

EDEJul 2023registered

Approved or registered in 5 of 7 markets

Connections

Insulin aspartmolecule Biocon Biologicsdeveloper 5 of 7markets 0trials behind it 8other products, same developer 3rival developers in its markets

About Kirsty

Kirsty is Biocon's insulin aspart, approved in Europe in 2021 under the name Kixelle and later renamed, in Canada the same year, and registered in the UAE in 2023 from Biocon's Malaysian plant. In July 2025 it was approved in the United States and became the first interchangeable insulin aspart on the day of approval.

Status by market

FDA

United States · Kirsty

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Novolog

Marketing status (Purple Book)

Prescription, marketed

Presentations

100 units/mL, 3 mL pen and 10 mL vial

Remarks

First interchangeable insulin aspart.

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Kirsty

European Medicines Agency and European CommissionApproved

Brand

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

Remarks

Authorised as Kixelle, renamed Kirsty.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Kirsty

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Kirsty

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

100 units/mL pen and vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Kirsty

Health CanadaApproved

Brand

Kirsty

Holder or applicant

Biocon Biologics Canada INC

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Oct 2021

Application or permission

DIN 02520974

Presentations

100 units/mL

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Kirsty

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

Where Kirsty holds an approval, these are the other insulin aspart biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	2	Not stated in the Purple Book (Garzulys), Sanofi (Merilog / Insulin aspart Sanofi)
EMA	2	Gan & Lee Pharmaceuticals (Dazparda), Sanofi (Merilog / Insulin aspart Sanofi)
MHRA	1	Sanofi (Merilog / Insulin aspart Sanofi)
HC	1	Sanofi (Merilog / Insulin aspart Sanofi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Ogivri / CANMAb, Semglee, Yesafili, Yesintek / Usrenty.

Chronology

EMAFeb 2021Authorised by the European Commission as Kirsty
HCOct 2021Notice of Compliance, Health Canada 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)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All insulin aspart biosimilars

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Data current to September 2026.