The agency said Sept. 17 that Byooviz, made by Samsung Bioepis, is a once-a-month treatment for diseases including neovascular age-related macular degeneration, a leading cause of vision loss and blindness for Americans 65 and older. It’s also approved to treat macular edema and myopic choroidal neovascularization.
“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,” Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a news release.
The FDA has now approved 31 biosimilars, which are drugs that are highly similar to a biological product already approved by the FDA but less expensive.
“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,” Dr. Yim said
Read the FDA’s full news release here.
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