On October 9, 2025, Celltrion announced the FDA approved Eydenzelt® (aflibercept-boav), a biosimilar of Regeneron’s EYLEA® (aflibercept). The FDA has previously approved five aflibercept biosimilars: Biocon / Mylan’s Yesafili™ (aflibercept-jbvf), Samsung Bioepis’s Opuviz™ (aflibercept-yszy), Formycon’s Ahzantive® (aflibercept-mrbb), Sandoz’s Enzeevu™ (aflibercept-abzv), and Amgen’s Pavblu™ (aflibercept-ayyh).
There are two ongoing patent disputes related to Eydenzelt®, Case No. 1:23-cv-00089 (N.D.W. Va.) and Case No. 1:24-cv-00053 (N.D.W. Va.) (consolidated as MDL 1:24-md-03103 (N.D.W. Va.)).
Numerous EYLEA® biosimilar litigations remain ongoing, including with Samsung Bioepis over Opuviz™ (Case Nos. 1:23-cv-00094 (N.D.W. Va.) / 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)); and Amgen over Pavblu™ (Case Nos. 1:24-cv-00039 (N.D.W. Va.) / 1:25-cv-00074 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)). Regeneron has settled the litigations related to Yesafili™, Enzeevu™, and Ahzantive® with launches starting in the second half of 2026 (previously reported Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™; Regeneron Settles Litigations with Sandoz and Formycon over EYLEA® Biosimilars Enzeevu™ and Ahzantive®).
Regeneron reported EYLEA® U.S. sales of $4.77 billion in FY2024.
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The authors would like to thank April Breyer Menon for her contributions to this article.
