Byooviz
Ranibizumab biosimilar developed by Samsung Bioepis, development code SB11. Reference product Lucentis.
About Byooviz
Byooviz is Samsung Bioepis's ranibizumab, sold by Biogen, and the first ranibizumab biosimilar approved in Europe and the United States, both in 2021. It became interchangeable in the United States in 2023. In Canada it is sold as Melvizo, approved in 2022. It was also the first biosimilar of any eye medicine in the West.
Status by market
United States · Byooviz
US Food and Drug AdministrationApprovedEuropean Union · Byooviz
European Medicines Agency and European CommissionApprovedUnited Kingdom · Byooviz
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada · Melvizo
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Byooviz 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 |
|---|---|---|---|---|---|---|---|---|
| SB11 | Samsung Bioepis | Lucentis | Phase 3 | Comparative efficacy | Completed | Mar 2018 | May 2019 | NCT03150589 |
Other developers in the same markets
Where Byooviz holds an approval, these are the other ranibizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Bioeq (Cimerli / Ranivisio), Lupin (Ranluspec / Vislyfa), Zydus Lifesciences (Nufymco) |
| EMA | 5 | Bioeq (Cimerli / Ranivisio), Intas Pharmaceuticals (Rexatilux / Razumab), Lupin (Ranluspec / Vislyfa), Qilu Pharmaceutical (Rimmyrah), Xbrane Biopharma (Ximluci) |
| MHRA | 4 | Lupin (Ranluspec / Vislyfa), Not stated in the MHRA list (Ongavia), Qilu Pharmaceutical (Rimmyrah), Xbrane Biopharma (Ximluci) |
| HC | 1 | Teva (Ranopto) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.
Chronology
- EMAAug 2021Authorised by the European Commission as Byooviz
- FDASep 2021Approved by FDA as Byooviz
- HCMar 2022Notice of Compliance, Health Canada as Melvizo
- 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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