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.
For more information on these biosimilars and other biosimilar patent disputes, please visit BiologicsHQ.
The author would like to thank April Breyer Menon for her contributions to this article.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.