In the last 2 weeks, Celltrion has received marketing approvals in the European Union and the United Kingdom for its ustekinumab, SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara®.
On 26 August 2024, Celltrion announced that the European Commission has approved its ustekinumab SteQeyma® for use in gastroenterology, dermatology and rheumatology indications. The European Commission’s decision follows the CHMP’s positive opinion for SteQeyma® in June 2024.
On 4 September 2024, the Korea Herald reported that Celltrion has received marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for SteQeyma®.
Ustekinumab biosimilars previously approved in the EU are Amgen’s Wezenla™, in June 2024, Sandoz/Samsung Bioepis’ Pyzchiva®, in April 2024, and Alvotech/Stada’s Uzpruvo®, in January 2024. Both Sandoz/Samsung Bioepis and Alvotech launched their ustekinumab biosimilars in the EU in July 2024. Also ahead of Celltrion are Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202), which received CHMP positive opinions in July 2024, and Bio-Thera’s MAA for BAT2206 (ustekinumab) which was accepted by EMA in July 2024. Pyzchiva®, Uzpruvo® and Wezenla™ have also been approved in the UK.