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EYLEA® Biosimilar Updates: Sandoz’s Enzeevu™ (aflibercept-abzv) FDA Approved, Regeneron Dismisses IPR Appeals

by Robert S. Schwartz, Ph.D.
August 19, 2024

On August 12, 2024, Sandoz announced the FDA approval of Enzeevu™ (aflibercept-abzv) as the fourth biosimilar of Regeneron’s EYLEA® (aflibercept).  Enzeevu™ was approved as provisionally interchangeable, subject to the unexpired first interchangeable exclusivity of Biocon’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™ (aflibercept-yszy), FDA approved in May 2024.  Formycon’s Ahzantive® (aflibercept-mrbb) was approved in June 2024.  All of the previously approved biosimilars are currently prevented from launching by preliminary injunctions (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars).  There are no pending biosimilar patent proceedings related to Enzeevu™.

On August 5, 2024, Regeneron filed a motion to dismiss in CAFC Appeal Nos. 24-1564 and 24-1567, which appealed the Final Written Decisions in Mylan’s IPR2022-01225 (IPR2023-00532 (Celltrion) joined) and IPR2022-01226 (IPR2023-00533 (Celltrion) and IPR2023-00566 (Samsung Bioepis) joined) finding the challenged claims of U.S. Patent Nos. 10,130,681 and 10,888,601 (“the ’601 patent”) unpatentable.  These dismissals follow Regeneron’s July requests for adverse judgment after disclaimer of other claims of the ’601 patent challenged by Samsung Bioepis in IPR2023-00739 (IPR2024-00201 (Biocon) joined) (previously reported Regeneron Dismisses IPR Appeals and Disclaims EYLEA® (aflibercept) Patents).

Regeneron reported EYLEA® sales of $5.89 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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