Skip to main content

Byooviz FDA Approval History

Last updated by Judith Stewart, BPharm on July 27, 2022.

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).

  • Byooviz is the first ophthalmology biosimilar approved in the United States and is the first biosimilar to Lucentis (ranibizumab).
  • The FDA approval of Byooviz was based on a review of safety and efficacy data that demonstrated Byooviz is biosimilar to Lucentis.
  • Unlike Lucentis, Byooviz is not FDA approved for the treatment of patients with diabetic macular edema (DME) or diabetic retinopathy (DR).
  • Byooviz is administered by intravitreal injection once a month.
  • Byooviz may cause adverse reactions including endophthalmitis and retinal detachments; increases in intraocular pressure; and thromboembolic events. Common side effects include conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular fluid pressure.

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 LucentisĀ® (ranibizumab)
Nov 11, 2020Samsung Bioepis Announces One-Year Results from Phase 3 Study of SB11, a Proposed Biosimilar to LucentisĀ® (ranibizumab)
May 18, 2020Samsung Bioepis Announces 24-week Interim Results from a Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.