On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab. Under the agreement, Bio-Thera will maintain responsibility for development, manufacture and supply of the biosimilar (to Roche’s RoActemra®), while STADA and its affiliates will have exclusive rights to commercialise the biosimilar in the EU, UK, Switzerland and selected other countries.
Bio-Thera and STADA have an existing agreement on similar terms in relation to the exclusive commercialisation of BAT2506 (biosimilar to J&J’s Simponi® (golimumab)), announced in May 2024. In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA).
Bio-Thera’s tocilizumab biosimilar, BAT1806, was the subject of a commercialisation and licence agreement with Biogen entered in April 2021. Biogen’s IV tocilizumab, Tofidence®, was approved in the EU in June 2024.
Other tocilizumab biosimilars currently approved in the EU are Fresenius Kabi’s Tyenne®, in both IV and SC forms, approved in November 2023 and Celltrion’s Avtozma®, approved in February 2025.