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) · Company profile

FDANot listed

EMANov 2022authorised

MHRALicenseddate not shown

PMDANot listed

HCNot listed

CDSCONot listed

EDEDec 2023registered

Approved or registered in 3 of 7 markets

Connections

Ranibizumabmolecule Xbrane Biopharmadeveloper 3 of 7markets 1trial behind it 0other products, same developer 6rival developers in its markets

About Ximluci

Ximluci is the ranibizumab developed by Xbrane of Sweden and sold by Stada, approved in Europe in November 2022. It is the only ranibizumab biosimilar registered in the UAE, since December 2023. It has not been filed in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Ximluci

European Medicines Agency and European CommissionApproved

Brand

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 (EMA) · checked Sep 2026

MHRA

United Kingdom · Ximluci

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Ximluci

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

10 mg/mL vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Ximluci

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Ximluci by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
Xlucane	Xbrane Biopharma	Lucentis	Phase 3	Comparative efficacy	Completed	Apr 2019	May 2021	NCT03805100

Other developers in the same markets

Where Ximluci holds an approval, these are the other ranibizumab biosimilars approved in that market.

Market	Rivals	Developers (product)
EMA	5	Bioeq (Cimerli / Ranivisio), Intas Pharmaceuticals (Rexatilux / Razumab), Lupin (Ranluspec / Vislyfa), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz)
MHRA	4	Lupin (Ranluspec / Vislyfa), Not stated in the MHRA list (Ongavia), Qilu Pharmaceutical (Rimmyrah), Samsung Bioepis (Byooviz)

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)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All ranibizumab biosimilars

Planning ranibizumab biosimilar development?

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Data current to September 2026.