Sun Pharma ranibizumab
Ranibizumab biosimilar developed by Sun Pharmaceutical Industries. Reference product Lucentis.
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Sun Pharma · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOMar 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Sun Pharma ranibizumab
Sun Pharma received its ranibizumab permission in India in March 2023, with diabetic macular oedema and vein occlusion added in 2024. It is one of Sun's few biosimilars.
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 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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Sun Pharma ranibizumab holds an approval, these are the other ranibizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 5 | Enzene Biosciences (Enzene Biosciences ranibizumab), Intas Pharmaceuticals (Rexatilux / Razumab), Lupin (Ranluspec / Vislyfa), Reliance Life Sciences (Reliance Life Sciences ranibizumab), Zenotech Laboratories (Zenotech ranibizumab) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Sun Pharmaceutical Industries: Teriparatide Sun.
Chronology
- CDSCOMar 2023CDSCO permission granted
Sources
Planning ranibizumab biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.