by April Breyer Menon | Jun 25, 2024
On June 13, 2024, the PTAB granted institution of IPR2024-00240 that Merck Sharp & Dohme, LLC (“Merck”) filed in November 2023 challenging claims 1-42 of The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”) on anticipation and...
by April Breyer Menon | Jun 13, 2024
On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan’s Yesafili™ (aflibercept-jbvf), a recently approved interchangeable biosimilar of...
by April Breyer Menon | Jun 11, 2024
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by April Breyer Menon | May 31, 2024
On May 28, 2024, the FDA approved Amgen’s Bkemv™ (eculizumab-aeeb), the first interchangeable biosimilar of Alexion’s Soliris® (eculizumab). Bkemv™ was approved with a skinny label for paroxysmal nocturnal hemoglobinuria (PNH) and atypical...
by April Breyer Menon | May 31, 2024
On May 28, 2024, Amgen filed a BPCIA litigation, Case No. 1:24-cv-06497 (D.N.J.), against Celltrion’s proposed Prolia® / Xgeva® (denosumab) biosimilar CT-P41 alleging infringement of 29 of Amgen’s patents, including one patent with formulation/composition...