Bio-Thera, STADA Extend Biosimilars Alliance to Tocilizumab

Bio-Thera Solutions, a commercial-stage biopharmaceutical company, and STADA Arzneimittel AG, a consumer healthcare medicines company, have agreed to extend their biosimilars alliance to cover tocilizumab.

Tocilizumab is an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions. The effectiveness of the agreement covering tocilizumab is subject to shareholder approval.

This agreement for tocilizumab builds upon an existing partnership on similar terms for BAT2506, a biosimilar candidate to Simponi (golimumab), that the two companies announced in May 20241. The European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for BAT2506.

Bio-Thera will maintain responsibility for the development, manufacturing, and supply of the tocilizumab biosimilar to Roche’s RoActemra reference brand. 

STADA, including its affiliates, will have exclusive rights to commercialize the biosimilar in the European Union (EU), the UK, Switzerland, and selected other countries under its own marketing authorization.

In June 2024, tocilizumab 20mg/ml concentrate for solution developed by Bio-Thera under the BAT1806 code received a marketing authorization for the vials that is valid throughout the EU2. This followed a positive opinion issued by the European Medicines Agency that the biosimilar to Roche’s RoActemra reference brand be approved as a medicine to treat several arthritic conditions.

“…Tocilizumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars that hold leading positions in several European countries. Bio-Thera’s expertise in developing and manufacturing biologic medicines makes it an appealing partner for STADA,” commented STADA’s head of Global Specialty, Ian Henshaw.