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On June 28, 2024, the FDA approved three new biosimilars, Formycon and Klinge Biopharma’s Ahzantive® (aflibercept-mrbb), a biosimilar of Regeneron’s EYLEA® (aflibercept); Tanvex Biopharma’s Nypozi™ (filgrastim-txid), a biosimilar of Amgen’s Neupogen® (filgrastim); and Samsung Bioepis and Sandoz’s Pyzchiva® (ustekinumab-ttwe), an interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).

Ahzantive® is the third EYLEA® biosimilar to receive FDA-approval, coming a little over a month after the approval of two interchangeable biosimilars, Biocon and Mylan’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™ (aflibercept-yszy)Regeneron and Formycon are currently involved in litigation over Ahzantive® (Case No. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), where the Court issued a preliminary injunction on June 21, 2024 preventing its commercial launch.  Formycon filed an appeal of that decision (CAFC 24-2009) on June 26, 2024.  Yesafili™ and Opuviz™ are also subject to permanent and preliminary injunctions preventing their commercial launches (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™).

Regeneron reported EYLEA® U.S. sales of $5.89 billion in 2023.

Nypozi™ is the fourth Neupogen® biosimilar to receive FDA-approval, after almost six years under FDA-review, which included two complete response letters from the FDA.  Amgen and Tanvex entered into a confidential settlement of their dispute related to Nypozi™ in December 2019 (Case No. 3:19-cv-01374 (S.D. Cal.).  Neupogen® biosimilars have been available in the U.S. since 2015, when Sandoz launched Zarxio® (filgrastim-sndz).  Since then, according to a recent market report from Samsung Bioepis, Neupogen® biosimilars have gained approximately 86% market share.

Pyzchiva® is the third Stelara® biosimilar to receive FDA-approval and the second to receive an interchangeability designation, following Amgen’s Wezlana™ (ustekinumab-auub), approved as an interchangeable biosimilar in October 2023, and Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), approved as a biosimilar in April 2024.  Samsung Bioepis entered into a settlement agreement with Janssen allowing Pyzchiva® to enter the U.S. market no later than February 22, 2025.  Amgen announced that under its settlement agreement, Wezlana™ can enter the U.S. market no later than January 1, 2025.

Johnson & Johnson reported Stelara® U.S. sales of $6.97B in 2023.

For more information on these biosimilars 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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