Garzulys
Insulin aspart biosimilar developed by Not stated in the Purple Book. Reference product NovoRapid (NovoLog in the United States).
Brands by market: Garzulys (USA) · Commercial partner or holder: Emerge Bioscience (US applicant)
FDAJul 2026approved
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Garzulys
Garzulys is an insulin aspart approved in the United States in July 2026, the third there. The licence is held by Emerge Bioscience, the company that also took over Yusimry, and the developer is not named in the Purple Book.
Status by market
FDA
United States · Garzulys
US Food and Drug AdministrationApprovedBrand
Garzulys
Holder or applicant
Emerge Bioscience Pte. Ltd.
Pathway
351(k)
Approved
Jul 2026
Application or permission
761497
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Novolog
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 units/mL, 3 mL pen and 10 mL vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Garzulys holds an approval, these are the other insulin aspart biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 2 | Biocon Biologics (Kirsty), Sanofi (Merilog / Insulin aspart Sanofi) |
Chronology
- FDAJul 2026Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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