The US Food and Drug Administration recently announced that it has approved 2 interchangeable biosimilars to Regeneron’s Eylea (aflibercept). The products are Yesafili (aflibercept-jbvf; Biocon Biologics) and Opuviz (aflibercept-yszy; Samsung Bioepis). Both Yesafili and Opuviz are administered intravitreally as a 2 mg injectable solution to treat patients for neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The FDA’s designation of “interchangeable biosimilar” means that Yesafili and Opuviz may be substituted for the reference product without consulting the prescriber, similar to how generic drugs are substituted for brand name drugs. However, it is unclear when these biosimilars will be available. Regeneron, which reported US net sales of more than $5.72 billion from Eylea in 2023,1 has filed patent-infringement lawsuits against numerous rival biotech companies seeking to make aflibercept biosimilars; in addition to Biocon and Samsung Bioepis, companies involved in pending litigation include Amgen, Celltrion, Formycon AG, and Viatris.
Reference
1. Regeneron reports fourth quarter and full year 2023 financial and operating results. News release. February 2, 2024. Accessed May 22, 2024. https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial
