In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.
Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under a licence and commercialisation agreement entered into with Bio-Thera in October 2024. Under the agreement, Bio-Thera is responsible for the development and manufacture of BAT2206 (ustekinumab), while Richter has commercialisation rights for the EU, UK and Switzerland.
BAT2206 was approved in the EU in August 2025 (as Usymro®), following a positive CHMP opinion in June 2025.
There are a number of ustekinumab biosimilars now marketed in the EU, including STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® (both launched in July 2024) and Celltrion’s Steqeyma® (launched November 2024). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).