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
CDSCOnot listed
EDEnot listed
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
Presentations
100 units/mL, 3 mL pen and 10 mL vial
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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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