Rexatilux / Razumab
Ranibizumab biosimilar developed by Intas Pharmaceuticals. Reference product Lucentis.
Brands by market: Rexatilux (EU); Razumab (India) · Commercial partner or holder: Intas Pharmaceuticals (Accord in the EU)
FDAnot listed
EMAJun 2026authorised
CDSCOFeb 2015permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Rexatilux
European Medicines Agency and European CommissionApprovedBrand
Rexatilux
Holder or applicant
Intas Third Party Sales 2005 S.L.
Pathway
Centralised (Article 10(4))
Approved
Jun 2026
Application or permission
EMEA/H/C/006634
Presentations
see SmPC
Source
S017
CDSCO
India · Razumab
Central Drugs Standard Control OrganisationApprovedBrand
Razumab
Holder or applicant
Intas Pharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Feb 2015
Application or permission
MF-35/2015; BULK-36/2015; additional indication July 2022 (retinopathy of prematurity)
Indications as licensed
Wet AMD, DME, RVO, CNV; retinopathy of prematurity added July 2022
Presentations
2.3 mg/0.23 mL single-use vial (10 mg/mL)
Note
First ranibizumab biosimilar approved anywhere.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOFeb 2015CDSCO permission granted as Razumab
- EMAJun 2026Authorised by the European Commission as Rexatilux
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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