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Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™

by Robert S. Schwartz, Ph.D.
April 25, 2025

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.

For more information about these and other biosimilar 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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