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Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

by Robert S. Schwartz, Ph.D.
August 28, 2024

Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of Regeneron’s patents, including two patents claiming methods of treatment, two patents claiming formulations, five patents claiming compositions of matter, 28 patents with manufacturing claims, five patents claiming devices, two patents with packaging claims, and eight design patents.  Ten of these patents have not been asserted by Regeneron in prior biosimilar litigations.  This is the first litigation related to an EYLEA® biosimilar that Regeneron has filed in the New Jersey District Court; the other seven litigations were all filed in the Northern District of West Virginia.

In the Complaint, Regeneron also alleges Sandoz violated the BPCIA by failing to provide Regeneron with any notice of its aBLA filing until it publicly announced Enzeevu™’s FDA approval on August 12, 2024 (see EYLEA® Biosimilar Updates: Sandoz’s Enzeevu™ (aflibercept-abzv) FDA Approved, Regeneron Dismisses IPR Appeals).

In the pending BPCIA litigations in West Virginia, preliminary injunctions were issued against the commercial launch of Samsung Bioepis’s 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’s Ahzantive® (aflibercept-mrbb) (Case Nos. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), and Celltrion’s CT-P42 (aflibercept) (Case Nos. 1:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars).  The West Virginia Court also entered a permanent injunction against Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) (Case Nos. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™).  A preliminary injunction hearing for Amgen’s Pavblu™ (aflibercept-ayyh) was held on August 13, 2024 and a decision is pending (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 $5.72 billion in 2023.

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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