Drug Topics May 24, 2024
Check out important updates from the FDA for the week of May 20.
FDA Approves Aflibercept (Eyela) Biosimilars, Yesafili and Opuviz
The FDA approved aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz), the first interchangeable biosimilars for aflibercept (Eyela). These medications are used to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The medications are vascular endothelial growth factor (VEGF) inhibitors, administered intravitreally as a 2 mg injectable solution. Anti-VEGF medications stop abnormal blood vessels from leaking, growing, and bleeding under the retina, which leads to pain and vision loss for patients.
FDA approval of both Yesafili and Opuviz were based on a “comprehensive review of scientific evidence demonstrating that each product is highly...
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