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ARTICLE · 27 SEPTEMBER 2024

Preliminary Injunction Against Amgen's EYLEA® Biosimilar Pavblu™ Denied

Venable LLP
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On September 23, 2024, Regeneron's motion for a preliminary injunction against the commercial launch of Amgen's EYLEA® (aflibercept)...

United StatesIntellectual Property
Robert S. Schwartz, Ph.D.
Robert S. Schwartz, Ph.D.

On September 23, 2024, Regeneron's motion for a preliminary injunction against the commercial launch of Amgen's EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh) was denied in Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.). The Order is currently sealed. Regeneron filed a notice of appeal on the same day the Order issued.

This outcome is a departure from previous decisions related to the same patent, Regeneron's U.S. Patent No. 11,084,865 (“the '865 patent”). In June 2024, the same Court granted preliminary injunctions based on the potential infringement of the '865 patent for three other EYLEA® biosimilars: Samsung Bioepis's Opuviz™ (aflibercept-yszy) (Case Nos. 1:23-cv-00094 (N.D.W. Va.), 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), Formycon's Ahzantive® (aflibercept-mrbb) (Case Nos. 1:23-cv-00097 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)), and Celltrion's CT-P42 (aflibercept) (Case Nos. 1:23-cv-00089 (N.D.W. Va.) /

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