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® (aflibercept) 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.
_____________________________________________________The authors would like to thank April Breyer Menon for her contributions to this article.
