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Byooviz FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 25, 2023.

FDA Approved: Yes (First approved September 17, 2021)
Brand name: Byooviz
Generic name: ranibizumab-nuna
Dosage form: Intravitreal Injection
Company: Samsung Bioepis Co., Ltd.
Treatment for: Macular Degeneration, Macular Edema, Myopic Choroidal Neovascularization

Byooviz (ranibizumab-nuna) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Development timeline for Byooviz

Sep 20, 2021Approval FDA Approves Byooviz (ranibizumab-nuna), a Biosimilar to Lucentis
Nov 18, 2020Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)
Nov 11, 2020Samsung Bioepis Announces One-Year Results from Phase 3 Study of SB11, a Proposed Biosimilar to Lucentis® (ranibizumab)
May 18, 2020Samsung Bioepis Announces 24-week Interim Results from a Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar

Further information

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