The United States Food and Drug Administration (FDA) has announced the approval of the first interchangeable biosimilars to aflibercept (Eylea), used to treat macular oedema.
The two newly approved biosimilars – aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz) – have the same approved indications as the reference product Eylea: diabetic macular oedema, diabetic retinopathy, macular oedema following retinal vein occlusion, and neovascular age-related macular degeneration (AMD).
Like Eylea, the biosimilars are administered via intravitreal injection.
According to the FDA, a biosimilar “has no clinically meaningful differences” from the reference product, meaning patients “can expect the same safety and effectiveness from the biosimilar as they would the reference product”.
The approvals followed a “comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea…”
Importantly, the interchangeable designation for Yesafili and Opuviz allows them to be substituted for Eylea without consulting the prescriber, just as generic drugs can be substituted for brand name drugs at the pharmacy level.
The approvals followed a “comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea… and that they have no clinically meaningful differences”.
