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FDA Approves Celltrion’s EYLEA® Biosimilar Eydenzelt®

by Leah Watson; Robert S. Schwartz, Ph.D.
October 16, 2025

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.

For more information on this and other biologic patent disputes, please visit BiologicsHQ.com.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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