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Regeneron Settles Litigations with Sandoz and Formycon over EYLEA® Biosimilars Enzeevu™ and Ahzantive®

by Robert S. Schwartz, Ph.D.; Leah Watson
September 29, 2025

On September 9, 2025, Sandoz announced it reached a settlement agreement with Regeneron, dismissing Case No. 1:24-cv-00085 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization of EYLEA® (aflibercept) interchangeable biosimilar Enzeevu™ (aflibercept-abzv) in the fourth quarter of 2026, or earlier under certain undisclosed circumstances.

On September 29, 2025, Formycon announced it reached a settlement agreement with Regeneron, dismissing Case No. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) regarding its EYLEA® interchangeable biosimilar Ahzantive® (aflibercept-mrbb) and vacating the preliminary injunction previously issued by the Court. The settlement agreement allows Formycon to launch Ahzantive® in the fourth quarter of 2026.

Sandoz and Formycon are the second and third companies to settle an EYLEA® biosimilar litigation after the Yesafili™ (aflibercept-jbvf) settlement in April 2025 (previously reported Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™). Other EYLEA® biosimilar litigations remain ongoing, including with Celltrion over CT-P42 (Case Nos. 1:23-cv-00089 (N.D.W. Va.) / 1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)); 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 No. 1:24-cv-00039 (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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