Ximluci
Ranibizumab biosimilar developed by Xbrane Biopharma, development code Xlucane. Reference product Lucentis.
Brands by market: Ximluci (EU, UAE) · Commercial partner or holder: Stada (EU, UAE)
FDAnot listed
EMANov 2022authorised
CDSCOnot listed
EDEDec 2023registered
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Ximluci
European Medicines Agency and European CommissionApprovedBrand
Ximluci
Holder or applicant
STADA Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Nov 2022
Application or permission
EMEA/H/C/005617
Indications as licensed
Wet AMD, DME, PDR, RVO, CNV
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Ximluci
Emirates Drug EstablishmentRegisteredBrand
Ximluci
Holder or applicant
STADA Arzneimittel AG, Germany · UAE supplier City Medical Store
Pathway
Registered medical product
Registered
Dec 2023
Presentations
10 mg/mL
Source
S018
Chronology
- EMANov 2022Authorised by the European Commission as Ximluci
- EDEDec 2023Registered in the UAE as Ximluci
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
Planning ranibizumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.