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News

Fifth EYLEA® Biosimilar FDA-Approved: Amgen’s Pavblu™ (aflibercept-ayyh)

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

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.

For more information about these and other biosimilars and related 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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