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EMA Seeks Input on a “Tailored Clinical Approach” in Biosimilar Development

On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development.  The reflection paper considers the need for current comparability studies, including Comparative Efficacy Studies (“CES”).  The reflection paper outlines various circumstances in which the other…

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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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Commercialization of Ustekinumab and Golimumab Biosimilars

This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia.  Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen’s STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s…

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