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News

Regeneron and Samsung Bioepis Settle EYLEA® BPCIA Litigations Related to Opuviz™

by Robert S. Schwartz, Ph.D.
February 18, 2026

On February 11, 2026, Regeneron and Samsung Bioepis dismissed Case Nos. 1:23-cv-00094 (N.D.W. Va.) and 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) due to settlement.  The preliminary injunction previously granted by the Court and affirmed by the Federal Circuit (previously reported Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon) was also vacated.  Under the settlement agreement, Samsung Bioepis can launch its EYLEA® (aflibercept) interchangeable biosimilar Opuviz™ (aflibercept-yszy) starting in January 2027.

Samsung Bioepis is the fifth company to settle an EYLEA® biosimilar litigation, following settlements for Yesafili™ (aflibercept-jbvf) in April 2025 (previously reported Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™), Enzeevu™ (aflibercept-abzv) and Ahzantive® (aflibercept-mrbb) in September 2025 (previously reported Regeneron Settles Litigations with Sandoz and Formycon over EYLEA® Biosimilars Enzeevu™ and Ahzantive®), and Eydenzelt® (aflibercept-boav) in October 2025 (previously reported Regeneron Settles Litigations with Celltrion over EYLEA® Biosimilar Eydenzelt®).

The only pending EYLEA® biosimilar litigations are with 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.)).  Amgen launched Pavblu™ at-risk in October 2024 (previously reported Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.), and recently reported $700 million in sales for 2025, with 21% quarter-over-quarter sales growth, as the only EYLEA® biosimilar on the market.

Regeneron reported EYLEA® U.S. sales of $2.75 billion in FY2025.

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

 

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The author 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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