On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization of EYLEA® (aflibercept) interchangeable biosimilar Yesafili™ (aflibercept-jbvf) in the second half of 2026, or earlier under certain undisclosed circumstances. Prior to the settlement agreement, the commercial launch of Yesafili™ was enjoined until the expiration of Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) in June 2027, after the Court found Yesafili™ infringed claims 4, 7, 9, 11, and 14-17. The Court also found Mylan and Biocon had not proven the claims invalid (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™; EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates).
While Amgen already launched its EYLEA® biosimilar Pavblu™ (adalimumab-ayyh) at-risk in October 2024 (previously reported Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.), Yesafili™ is likely to be the first interchangeable biosimilar of EYLEA® to launch.
Biocon is the first to settle an EYLEA® biosimilar litigation, and numerous other 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.)); Formycon over Ahzantive® (aflibercept-mrbb) (Case No. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)); Amgen over Pavblu™ (Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)); and Sandoz over Enzeevu™ (aflibercept-abzv) (Case No. 1:24-cv-00085 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)). Preliminary injunctions have been issued preventing the commercial launch of CT-P42, Opuviz™, and Ahzantive®.
Samsung Bioepis, Formycon, and Celltrion have all filed IPRs against the ’865 patent that are awaiting institution decisions (IPR2025-00176, IPR2025-00233, and IPR2025-00456 respectively).
Regeneron reported EYLEA® U.S. sales of $4.767 billion in FY2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
