Amgen announced during its Q3 2024 Earnings Call that it had launched Pavblu™ (aflibercept-ayyh) as the first biosimilar of Regeneron’s EYLEA® (aflibercept) to be marketed in the U.S. The launch follows the Federal Circuit’s decision on October 22, 2024 (CAFC Appeal No. 24-2351) to deny a temporary injunction that would prevent Pavblu™ from launching at-risk while Regeneron appeals an earlier District Court (Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) denial of a preliminary injunction against Pavblu™ (previously reported Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction). The litigation and appeal remain ongoing.
Numerous other EYLEA® biosimilars have had their launches delayed by preliminary injunctions, including Samsung Bioepis’s Opuviz™ (aflibercept-yszy), Formycon’s Ahzantive® (aflibercept-mrbb), and Celltrion’s CT-P42 (aflibercept) (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars). Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) has been permanently enjoined from launching prior to the expiration of Regeneron’s U.S. Patent No. 11,084,865 (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™).
Regeneron reported EYLEA® sales of $5.72 billion in 2023.
There are currently eight ongoing litigations and related appeals for EYLEA® biosimilars.
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The author would like to thank April Breyer Menon for her contributions to this article.
