The FDA approved ranibizumab-nuna (Byooviz), the first biosimilar to ranibizumab injection (Lucentis), to treat a host of eye diseases and conditions, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
Age-related macular degeneration comes in two varieties: dry and wet. While dry AMD is the more common of the two, the FDA explained, wet AMD causes vision loss at a much faster rate and is one of the most common causes of vision loss and blindness in individuals age 65 years and older. And, the agency added, both macular edema and myopic choroidal neovascularization can lead to impaired vision.
This new biosimilar “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,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, wrote in a statement.
As this drug is a biosimilar to a pre-existing product, the FDA noted that patients can expect the same safety and efficacy from the treatment. The approval was based on a review of evidence that included extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity,” which demonstrated the drug’s biosimilarity to the original product.
Ranibizumab-nuna is indicated as a monthly intravitreal injection. The agency warned that the drug can cause serious side effects, including endophthalmitis and retinal detachments; increased intraocular pressure; and thromboembolic events. The most common side effects include conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular fluid pressure.
Ranibizumab-nuna is manufactured by Samsung Bioepis.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 240
Topic ID: 92,240,494,730,192,725,925,240
