by April Breyer Menon | May 28, 2024
On May 27, 2024, Fresenius Kabi announced the FDA acceptance of its aBLA for FKS518 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). This is the third publicly announced aBLA for a Prolia® / Xgeva® biosimilar; Sandoz’s Jubbonti® / Wyost®...
by April Breyer Menon | May 23, 2024
On May 17, 2024, Regeneron filed a second infringement litigation against Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42, Case No. 1:24-cv-00053 (N.D.W. Va.). The aBLA for CT-P42 was submitted to the FDA in June 2023. Regeneron’s Complaint listed...
by April Breyer Menon | May 22, 2024
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April. On March 19, 2024, Alexion Pharmaceuticals (a subsidiary...
by April Breyer Menon | May 21, 2024
On May 20, 2024, the FDA approved the first two interchangeable biosimilars of Regeneron’s EYLEA® (aflibercept) – Biocon Biologics and Mylan’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™ (aflibercept-yszy). There are at...
by April Breyer Menon | May 16, 2024
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