Date: 2025-08-25Click:
Guangzhou, China/Bad Vilbel, Germany – 22 August 2025 – 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 2024[1].
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 EU[2]. 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.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and Usymro®(ustekinumab) in EU, and BAT1806/TOFIDENCE™ (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in China. In addition, the company has more than 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). For more information, please visit www.bohuijtss.com/en/ or follow us on X(@bio_thera_soln) and WeChat (Bio-Thera).
[1] Bio-Thera Solutions, Ltd.,; Bio-Thera and STADA Reach Exclusive Agreement for BAT2506 | STADA
[2] Union Register of medicinal products - Public health - European Commission