Tagged as: Amgen

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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Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the treatment of certain types of osteoporosis and bone loss.  JUBEREQ is indicated for the prevention of certain…

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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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