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Preliminary Injunction Against Amgen’s EYLEA® Biosimilar Pavblu™ Denied

by Robert S. Schwartz, Ph.D.
September 25, 2024

On September 23, 2024, Regeneron’s motion for a preliminary injunction against the commercial launch of Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh) was denied in Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.).  The Order is currently sealed.  Regeneron filed CAFC Appeal No. 24-2351 on the same day the Order issued.  On September 24, 2024, Regeneron filed a motion for a temporary injunction pending appeal.  On September 25, 2024, the Federal Circuit issued a temporary injunction preventing Pavblu™’s launch while the Court considers the motion for injunction pending appeal.

This outcome is a departure from previous decisions related to the same patent, Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”).  In June 2024, the same Court granted preliminary injunctions based on the potential infringement of the ’865 patent for three other EYLEA® biosimilars: 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 N.D.W. Va. 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.)) after a trial finding that Yesafili™ infringes claims 4, 7, 9, 11, and 14-17 of the ’865 patent and that those claims are valid (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™; EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates).

Numerous appeals are ongoing related to the aforementioned injunctions, including Samsung Bioepis’s CAFC Appeal Nos. 24-1965 24-1966, 24-2082, and 24-2083; Formycon’s 24-2009, 24-2019, and 24-2156; Celltrion’s 24-2058 and 24-2147; and Biocon / Mylan’s 24-2002.

Regeneron reported EYLEA® 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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