by April Breyer Menon | Oct 10, 2025
Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit...
by April Breyer Menon | Oct 1, 2025
On October 1, 2025, the FDA approved Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). This is the seventh Prolia® / Xgeva® biosimilar approval, and follows Biocon’s Bosaya™ /...
by April Breyer Menon | Sep 30, 2025
On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally interchangeable biosimilars Bosaya™ /...
by April Breyer Menon | Sep 29, 2025
On September 9, 2025, Sandoz announced it reached a settlement agreement with Regeneron, dismissing Case No. 1:24-cv-00085 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization of EYLEA® (aflibercept) interchangeable...
by April Breyer Menon | Sep 28, 2025
On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab). This is the only currently pending publicly announced aBLA for a Xolair® biosimilar, and...