The Commission moves forward with the steps outlined in Article 18 (2) of Regulation (EC) No 1107/2009.

STADA and Bio-Thera Expand Partnership for Tocilizumab Biosimilar

In a significant development, STADA Arzneimittel AG and Bio-Thera Solutions, Ltd. have announced an expansion of their biosimilars partnership. This agreement, announced on August 25, 2025, covers the targeted immunomodulatory monoclonal antibody, tocilizumab.

Tocilizumab is a key treatment for various inflammatory and autoimmune disorders, targeting the interleukin-6 receptor. The European Medicines Agency (EMA) has approved Bio-Thera's BAT1806 as a biosimilar to Roche's RoActemra reference product.

Under the terms of the agreement, Bio-Thera will be responsible for the development, manufacturing, and supply of the biosimilar. STADA, including its affiliates, will have exclusive rights to commercialize the product in the EU, UK, Switzerland, and selected other countries under its own marketing authorization.

The marketing authorization for BAT1806 was granted by the EMA in June 2024, marking a significant milestone in the collaboration. This agreement for tocilizumab builds upon an existing partnership between the two companies for BAT2506, a biosimilar candidate to Simponi® (golimumab).

Bio-Thera, based in Guangzhou, China, has over 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). The company also has five approved products, including QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCETM (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and EU, a/k/a POBEVCY® in China.

STADA, headquartered in Bad Vilbel, Germany, reported group revenues of € 4,059 million and adjusted constant-currency earnings before interest, taxes, depreciation, and amortization (adj. cc EBITDA) of € 886 million in the financial year 2024. The company's strategy revolves around three pillars: consumer healthcare products, generics, and specialty pharma.

The effectiveness of the agreement covering tocilizumab is subject to shareholder approval. Once approved, this partnership is set to strengthen STADA's position in the biosimilars market and provide patients with a more affordable treatment option for inflammatory and autoimmune disorders.