FDA Approves First Two Aflibercept 2mg Biosimilars With Interchangeability

FDA Approves First Two Aflibercept 2mg Biosimilars With Interchangeability

The U.S. Food and Drug Administration (FDA) announced Monday that two biosimilars to Eylea (Aflibercept; Regeneron, New York, USA) have received marketing approval.

The double nod from the United States’ top regulatory body for Yesafili (Biocon Biologics, Bengaluru, India) as well as Opuviz (Samsung Bioepis, Incheon, South Korea; and Biogen, Massachusetts, United States) is the first of its kind for biosimilars to Regeneron’s blockbuster treatment for exudative retinal disease.

“FDA’s approvals of Yesafili and Opuviz are based on a comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea, respectively, and that they have no clinically meaningful differences from Eylea,” the agency wrote in a statement.

“This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients.”

Critically, these drugs have also been granted full interchangeability and can be substituted for Eylea without consulting the prescriber, including at the pharmacy level—similar to the substitution of generic drugs for their brand-name equivalents.

The FDA has indicated that Yesafili and Opuviz are cleared for the treatment of neovascular or wet AMD (nAMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO) and diabetic retinopathy (DR).

Despite receiving regulatory approval, the future of Yesafili and Opuviz in the United States’ lucrative market remains unclear. Aflibercept biosimilars have been the target of a battery of lawsuits, including a recently settled lawsuit against Biocon in Canada.

Yesafili was also the first Eylea biosimilar to receive approval from the European Union’s regulatory agency in October 2023.

The approval comes at a heady time in the worldwide anti-VEGF market. Aside from the loss of exclusivity in the United States for Eylea from biosimilar competition, the drug is also facing pressure from Vabysmo (Faricimab-svoa; Roche, Basel, Switzerland).

Regeneron’s counterpunch to these threats to Eylea’s 2023 U.S. sales of USD 5.72 billion is the recently approved higher-dose Eylea HD (aflibercept 8mg).

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