The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) because the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related degeneration (nAMD), a number one explanation for vision loss and blindness for Americans aged 65 years and older. Byooviz is additionally approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins within the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).
“Today’s approval provides another treatment option for many people whose vision is impaired and is another breakthrough in our commitment to supply access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars within the FDA’s Center for Drug Evaluation and Research. “Continuing to grow the amount of biosimilar approvals may be a key a part of our efforts to supply greater access to treatment options for patients, increase competition and potentially lower costs.”
Neovascular (wet) age-related degeneration destroys the sharp, sight needed to ascertain clearly and may affect daily activities like reading, driving and watching television. There are two sorts of AMD—dry and wet. While dry AMD is more common, wet AMD results in vision loss at a faster rate. Both macular edema and myopic choroidal neovascularization also can cause visual defect .
Biological products are generally derived from a living organism and may come from many sources, including animals and microorganisms, like bacteria or yeast. A biosimilar may be a biological product that’s approved supported data showing that it’s highly almost like a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, additionally to meeting other criteria specified by law. Patients can expect an equivalent safety and effectiveness from the biosimilar over the course of treatment as from the reference product.
The FDA’s approval of Byooviz was supported a review of evidence that included extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity (type of immune response) that demonstrated Byooviz is biosimilar to Lucentis.
To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar, for the treatment of a spread of health conditions.
Byooviz is run by intravitreal injection (delivered into the vitreous humour of the eye) once a month. 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 vessel by a blood clot) events. the foremost common side effects of Byooviz include conjunctival hemorrhage (broken blood vessel), eye pain, vitreous floaters (black spots that drift across the eye) and increased intraocular fluid pressure.
FDA: Information on Biosimilars
Congress, through the Biologics price war and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as how to supply more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. meaning patients and health care professionals are going to be ready to depend on the security (and effectiveness of the biosimilar or interchangeable product, even as they might the reference product.
The FDA granted approval of Byooviz to Samsung Bioepis.
FDA: Biosimilar Product Information
Biosimilar and Interchangeable Products | FDA
Purple Book Database of Licensed Biological Products
Source link: https://www.fda.gov/