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Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved

Aug 26, 2025

On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The approval follows the European Medicine Agency’s CHMP positive opinion for the biosimilar on 20 June 2025.

BAT2206 will be commercialised in Europe by Gedeon Richter under the brand name Usymro® subject to a licence and commercialisation agreement entered into with Bio-Thera for Usymro®/BAT2206 in October 2024.  Bio-Thera is responsible for the development and manufacture and Gedeon Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it will be commercialised by Hikma under the name Starjemza®.

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in 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).