Enzene Biosciences ranibizumab
Ranibizumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Lucentis.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Enzene Biosciences
FDAnot listed
EMAnot listed
CDSCOAug 2023permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2023CDSCO permission granted
Sources
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