The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases.
Byooviz (ranibizumab-nuna) is the first biosimilar to Lucentis (ranibizumab injection). It treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment involves an intravitreal injection (delivered into the eye’s vitreous humor) once a month.
According to a news release, Byooviz also holds approval for treating macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).
The FDA’s approval came on the back of evidence that demonstrated that Byooviz is biosimilar to Lucentis through structural and functional characterization. Evidence also demonstrated comparative clinical efficacy and safety evaluations, including potential immunogenicity, according to Samsung Bioepis.
Administration of Byooviz may cause serious side effects, including endophthalmitis (infection inside the eye) and retinal detachments; increases in intraocular (inside the eye) pressure; and thromboembolic (obstruction of a blood vessel by a blood clot) events. The most common side effects of Byooviz, according to Samsung Bioepis, include conjunctival hemorrhage (broken blood vessel), eye pain, vitreous floaters (black spots that drift across the eye) and increased intraocular fluid pressure.
“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” director of the Office of Therapeutic Biologics and Biosimilars of the FDA Center for Drug Evaluation & Research Dr. Sarah Yim said in the release. “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”
