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Regeneron Settles Litigations with Celltrion over EYLEA® Biosimilar Eydenzelt®

by Leah Watson; Robert S. Schwartz, Ph.D.
October 23, 2025

On October 20, 2025, Celltrion and Regeneron announced they reached a settlement agreement, dismissing Case Nos. 1-23-cv-00089 (N.D.W. Va.) and 1-24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization of EYLEA® (aflibercept) biosimilar Eydenzelt® (aflibercept-boav) as of December 31, 2026.

Celltrion is the fourth company to settle an EYLEA® biosimilar litigation after the Yesafili™ (aflibercept-jbvf) settlement in April (previously reported Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™) and the Enzeevu™ (aflibercept-abzv) and Ahzantive® (aflibercept-mrbb) settlements in September (previously reported Regeneron Settles Litigations with Sandoz and Formycon over EYLEA® Biosimilars Enzeevu™ and Ahzantive®). Other EYLEA® biosimilar litigations remain ongoing, including with Samsung Bioepis over Opuviz™ (aflibercept-yszy) (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™ (aflibercept-ayyh) (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 reported EYLEA® U.S. sales of $4.77 billion in FY2024.

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

 

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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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