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Enzene Biosciences ranibizumab

Ranibizumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Lucentis.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Enzene Biosciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
RanibizumabmoleculeEnzene Biosciencesdeveloper1 of 7markets0trials behind it5other products, same developer5rival developers in its markets

About Enzene Biosciences ranibizumab

Enzene received its ranibizumab permission in India in August 2023 for wet macular degeneration, adding to its adalimumab, bevacizumab, denosumab and pertuzumab.

Status by market

FDA

United States

Not listed by FDA.

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

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2023
Application or permission
MF/BIO/23/000080; drug substance MF/BIO/24/000002
Indications as licensed
Wet AMD
Presentations
10 mg/mL vial
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Enzene Biosciences ranibizumab holds an approval, these are the other ranibizumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO5Intas Pharmaceuticals (Rexatilux / Razumab), Lupin (Ranluspec / Vislyfa), Reliance Life Sciences (Reliance Life Sciences ranibizumab), Sun Pharmaceutical Industries (Sun Pharma ranibizumab), Zenotech Laboratories (Zenotech ranibizumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Enzene Biosciences: Enzene Biosciences adalimumab, Enzene Biosciences bevacizumab, Enzene Biosciences pertuzumab, Enzene Biosciences teriparatide, Osqay / Enzene denosumab.

Chronology

Sources

All ranibizumab biosimilars

Planning ranibizumab biosimilar development?

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Data current to September 2026.