On August 23, 2024, the FDA approved Amgen’s Pavblu™ (aflibercept-ayyh) as the fifth biosimilar of Regeneron’s EYLEA^® (aflibercept).  Pavblu™ was approved with a skinny label that includes neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy indications.  The label carves out EYLEA^®’s retinopathy of prematurity indication.

Amgen and Regeneron are currently involved in a BPCIA litigation (Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) related to Pavblu™.  On August 13, 2024, the Court held a preliminary injunction hearing to determine whether Amgen will be prevented from launching Pavblu™ at-risk.  A decision is pending.

The Court has previously issued preliminary injunctions 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).  It 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™).

Regeneron reported EYLEA^® U.S. sales of $5.72 billion in 2023.

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The author would like to thank April Breyer Menon for her contributions to this article.