The FDA has approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Eylea (aflibercept) for the treatment of various eye conditions, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Aflibercept products work by inhibiting vascular endothelial growth factor, which helps slow down or reduce damage to the retina and preserve vision. Both Yesafili and Opuviz are administered intravitreally as a 2 mg injectable solution, following the recommended dosing regimens.
The approval of these interchangeable biosimilars was based on a comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea and has no clinically meaningful differences. The evidence included analytical comparisons using physicochemical tests and biological assays, as well as comparative clinical studies in patients.
Interchangeable biosimilars meet additional requirements under the law and may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws. This practice, known as "pharmacy-level substitution," is similar to how generic drugs are substituted for brand-name drugs.
The most common side effects (≥ 5%) observed in clinical studies of Yesafili and Opuviz included conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. Risks and contraindications are similar to those associated with Eylea.