FDA Approves First Interchangeable Biosimilars to Aflibercept for AMD

The FDA approved the first interchangeable biosimilars to aflibercept (Eylea) to treat macular degeneration, according to an announcement from the agency.

As interchangeable biosimilars, aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz) have the same approved indications as the reference product: diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration (AMD). Like reference aflibercept, the two biosimilars are administered via intravitreal injection.

The FDA pointed out in the announcement that a biosimilar “has no clinically meaningful differences” from the reference product, which means that patients “can expect the same safety and effectiveness from the biosimilar as they would the reference product.” Interchangeability means that the biosimilar met other requirements and may be substituted for the reference product without consulting the prescriber.

“Substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state … similar to how generic drugs are substituted for brand-name drugs,” the announcement continued.

Approval of the biosimilars to aflibercept occurred after a “comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea … and that they have no clinically meaningful differences from Eylea.” Studies included analytical comparison of the biosimilars’ physicochemical and biological properties with those of reference aflibercept. Additionally, a comparative clinical study was required.

“The totality of these data supported FDA approval of Yesafili and Opuviz as interchangeable biosimilars to Eylea,” agency officials stated.

Side effects and adverse events in clinical studies of the two biosimilars were consistent with those observed with reference aflibercept.

The FDA granted approval of Yesafili to India-based Biocon Biologics, and Samsung Bioepis and Biogen received the approval for Opuviz.

The FDA previously approved ranibizumab-nuna (Byooviz), a Biogen/Samsung Bioepis biosimilar to reference ranibizumab (Lucentis) for neovascular AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

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