Nufymco
Ranibizumab biosimilar developed by Zydus Lifesciences. Reference product Lucentis.
Brands by market: Nufymco (USA) · Commercial partner or holder: Zydus Lifesciences
FDADec 2025approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Nufymco
US Food and Drug AdministrationApprovedBrand
Nufymco
Holder or applicant
Zydus Lifesciences Global FZE
Pathway
351(k)
Approved
Dec 2025
Application or permission
761473
Licence type
351(k) interchangeable, designated Dec 2025
Presentations
10 mg/mL and 6 mg/mL
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
- FDADec 2025Approved 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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