On 4 November 2024, the Korea Hearld reported that Celltrion has launched SteQeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in Germany and the Netherlands. At the same time, the Korea Herald reported that Celltrion has already secured a bid from the Dutch pharmaceutical procurement group, iZAAZ, which will cover approximately 27% of the ustekinumab market in the Netherlands, with SteQeyma® expected to be supplied for about two years starting this month. Celltrion plans to launch SteQeyma® in Finland in mid-November and in Ireland in late November 2024.
Celltrion is 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. Then, on 25 July 2024, Sandoz announced the European launch of Pyzchiva®. We can expect more ustekinumab biosimilar launches in Europe in the coming months, with many companies having already received EMA regulatory approval. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.