Tagged as: Samsung Bioepis

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”).  The ’865 patent issued on August 10, 2021 and is…

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Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva

Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors. Earlier this year, Samsung also…

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District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case

On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”) from launching a private label biosimilar of Janssen’s STELARA® (ustekinumab) in a breach of contract…

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Global Biosimilar Updates - Spring 2025

GLOBAL BIOSIMILAR UPDATES Celltrion Bolsters Biosimilars Market Position in Italy Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025.  Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle d’Aosta, Liguria, and Sardegna.  Combined, these contracts…

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