• Bio-Thera and STADA agree to extend their biosimilars alliance to cover tocilizumab, a targeted immunomodulatory monoclonal antibody directed against the interleukin-6 receptor, indicated for the treatment of multiple inflammatory and autoimmune disorders
• Bio-Thera will have responsibility for development, manufacturing, and supply of the biosimilar to Roche's RoActemra^® reference brand
• STADA will have exclusive rights to commercialize the product in the EU, the UK, Switzerland and selected other countries under its own marketing authorization

Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have agreed to extend their biosimilars alliance to cover tocilizumab, an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions. The effectiveness of the agreement covering tocilizumab is subject to shareholder approval.

Bio-Thera will maintain responsibility for 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.

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. A marketing authorization application (MAA) for BAT2506 has subsequently been accepted by the European Medicines Agency (EMA).

"Benefiting from a proven track record in immunology, STADA ranks among the premier biosimilar companies in Europe," said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to extending our partnership to bring biosimilar tocilizumab to patients in Europe."

"With global RoActemra/Actemra sales in 2024 reported at approximately €2.8 billion, including around US$700 million in Europe despite the advent of biosimilar competition, 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.

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.