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Celltrion’s Ustekinumab Biosimilar Recommended by EMA’s CHMP

Jul 1, 2024

On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. CHMP’s recommendation is a key step in the European Commission’s final approval process, with approval imminently anticipated.  
CHMP’s recommendation follows Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024. Celltrion is also seeking approval for Steqeyma in the United States, and Australia, submitting applications with FDA in June 2023, and TGA in April 2023.