On 25 July 2024, Sandoz announced the European launch of Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab) for treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis. Although Pyzchiva® is not the first approved ustekinumab product in EU (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it is the first ustekinumab biosimilar to be available in all reference medicine strengths.
Pzychiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024. It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.
Amgen’s WezenlaTM has also been approved in Europe (June 2024). The CHMP has recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab) (1 July 2024) and, at its July meeting, adopted positive opinions for three more ustekinumab biosimilars: Samsung Bioepis’ Eksunbi, Formycon’s Fymskina (FYB202) and Fresenius Kabi’s Otulfi (FYB202). Bio-Thera is behind the race on this molecule, announcing on 24 July 2024 that its MAA for BAT2206 (ustekinumab) was EMA accepted.