Tagged as: BPCIA litigation

Genentech Files First Pertuzumab BPCIA Complaint Against Shanghai Henlius and Organon

On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. (together, “Henlius”) and Organon LLC and Organon & Co. (together, “Organon”) seeking approval…

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Amgen Files BPCIA Complaints Against Biocon, Shanghai Henlius/Organon and Hikma/Gideon Richter Regarding Denosumab Biosimilars

In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…

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