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).
- Byooviz was the first ophthalmology biosimilar to be approved in the United States and was the first biosimilar to Lucentis (ranibizumab).
- Byooviz was granted interchangeable status by the FDA on October 3, 2023.
- 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
Further information
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