Nufymco

Ranibizumab biosimilar developed by Zydus Lifesciences. Reference product Lucentis.

Brands by market: Nufymco (USA) · Commercial partner or holder: Zydus Lifesciences · Company profile
FDADec 2025approved
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Nufymco

Nufymco is Zydus's ranibizumab, approved in the United States in December 2025 and interchangeable from the start. It was the first ranibizumab biosimilar from an Indian company to reach the United States, and one of Zydus's first US biosimilar approvals.

Status by market

FDA

United States · Nufymco

US Food and Drug AdministrationApproved
Brand
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
Reference product in the Purple Book
Lucentis
Marketing status (Purple Book)
Prescription, marketed
Presentations
10 mg/mL and 6 mg/mL
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 Nufymco holds an approval, these are the other ranibizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA3Bioeq (Cimerli / Ranivisio), Lupin (Ranluspec / Vislyfa), Samsung Bioepis (Byooviz)

Same developer, other molecules

Other biosimilars in the Atlas developed by Zydus Lifesciences: Exemptia / Cadalimab, Zydus aflibercept, Zydus bevacizumab, Zydus epoetin, Zydus follitropin alfa, Zydus peginterferon alfa-2b, Zydus pertuzumab, Zydus rituximab, Zydus teriparatide, Zydus trastuzumab.

Chronology

Sources

All ranibizumab biosimilars

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Data current to September 2026.