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Positive CHMP Opinion for Celltrion’s Ustekinumab Biosimilar

Jun 27, 2024

At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  The recommendation is for moderately to severely active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis. 

This news follows approval of Steqeyma in South Korea earlier this month.  Celltrion is also seeking approval for Steqeyma in the US (FDA application submitted in June 2023) and Australia (TGA application submitted in April 2023). 

Ustekinumab biosimilars currently approved in Europe are Alvotech and STADA’s Uzpruvo® (January 2024) and Samsung Bioepis’ Pyzchiva® (April 2024).  Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.