Sun Pharma ranibizumab
Ranibizumab biosimilar developed by Sun Pharmaceutical Industries. Reference product Lucentis.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Sun Pharma
FDAnot listed
EMAnot listed
CDSCOMar 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
Sun Pharmaceutical Industries Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2023
Application or permission
MF/BIO/23/000020; additional indications MF/BIO/24/000006
Indications as licensed
Wet AMD at permission; DME and RVO added January 2024
Presentations
10 mg/mL single-use vial
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOMar 2023CDSCO permission granted
Sources
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