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 $5.72 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.