Introducing BYOOVIZ: A Biosimilar* Referencing Lucentis1
- FDA-approved for the treatment of nAMD, macular edema following RVO, and mCNV1
- Similar efficacy and comparable safety and immunogenicity2,3
- No clinically meaningful differences
from Lucentis based on the totality of evidence2,3
- 0.5 mg (0.05 mL of 10 mg/mL) dosing administered by intravitreal injection once a month1
- Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
BYOOVIZ Met FDA Requirements for Biosimilar Approval in All Studies Conducted2-5
BYOOVIZ was evaluated for biosimilarity in an nAMD clinical study and was granted approval for macular edema following RVO and mCNV through a process called "extrapolation." Extrapolation of clinical data to other indications of the reference product is considered in light of the totality of evidence and must be scientifically justified.1-6
BYOOVIZ is FDA-approved for the treatment of nAMD, macular edema following RVO, and mCNV1FDA=US Food and Drug Administration; mCNV=myopic choroidal neovascularization; nAMD=neovascular age-related macular degeneration; RVO=retinal vein occlusion.