Byooviz
Ranibizumab biosimilar developed by Samsung Bioepis, development code SB11. Reference product Lucentis.
Brands by market: Byooviz (USA, EU) · Commercial partner or holder: Biogen (USA, EU)
FDASep 2021approved
EMAAug 2021authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Byooviz
US Food and Drug AdministrationApprovedBrand
Byooviz
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Sep 2021
Application or permission
761202
Licence type
351(k) interchangeable, designated Oct 2023
Presentations
10 mg/mL vial
Note
First FDA-approved ophthalmology biosimilar.
Source
S001, S016
EMA
European Union · Byooviz
European Medicines Agency and European CommissionApprovedBrand
Byooviz
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Aug 2021
Application or permission
EMEA/H/C/005545
Indications as licensed
Wet AMD, DME, PDR, RVO, CNV
Presentations
see SmPC
Note
First EU ranibizumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAAug 2021Authorised by the European Commission as Byooviz
- FDASep 2021Approved by FDA as Byooviz
- FDAOct 2023Byooviz designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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