Lexology July 3, 2024
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...
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