On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany.
Steqeyma® was launched in France on 20 January 2025, Italy and Spain in mid-January 2025, the UK on 2 December 2024, and Germany in November 2024.
Celltrion was the third company to launch an ustekinumab biosimilar in Europe. On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® across the majority of European countries. This was quickly followed by Sandoz announcing the European launch of Pyzchiva® on 25 July 2024.
Steqeyma® was approved in Europe in August 2024, following a positive CHMP opinion in June 2024. It received approval in the UK in September 2024.
On 17 December 2024, Celltrion announced that the US FDA had approved Steqeyma®. According to Celltrion it is in the planning stages for the US launch of the product.