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), a 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, following Amgen’s Wezlana™ (ustekinumab-auub), approved as an interchangeable biosimilar in October 2023, and Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), approved 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.
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The author would like to thank April Breyer Menon for her contributions to this article.
