By SPC Staff
The FDA approved Yesafili (aflibercept-jbvf, Biocon Biologics) and Opuviz (aflibercept-yszy, Biogen) as interchangeable biosimilars to Eylea (aflibercept, Regeneron) to treat macular degeneration and several other eye conditions. 
These drugs inhibit vascular endothelial growth factor to prevent abnormal blood vessel growth in the eye and minimize damage to the retina. Both Yesafili and Opuviz treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. They are administered intravitreally as 2-mg injectable solutions.
“Biosimilars are crucial for making healthcare more affordable and accessible,” Matt Erick, the chief commercial officer of advanced markets for Biocon Biologics, said in a statement. “Yesafili will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy.”
The FDA approvals were based on data comparing the two biosimilars with Eylea that indicated no clinically meaningful differences from the reference product with respect to efficacy, safety and immunogenicity. The side effects in these studies were consistent with those observed in Eylea, with the most common (≥5%) being subconjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters and increased intraocular pressure. Contraindications include ocular or periocular infection, active intraocular inflammation, and hypersensitivity. Additional warnings outlined in the prescribing information include arterial thromboembolic events and endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion.
The full prescribing information for Yesafili and Opuviz can be found here.
Based on FDA and company press materials
