Bio‑Thera Expands Tocilizumab Biosimilar Reach Through STADA Partnership

Chinese biopharma Bio‑Thera Solutions and Germany’s STADA have signed an expanded licensing and commercialization agreement for BAT1806, a tocilizumab biosimilar referencing Actemra®/RoActemra®. Under the deal, STADA gains exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland, select European countries, key MENA markets, and certain CIS countries, while Bio‑Thera continues to handle development, manufacturing, and supply.

The agreement is valued at up to €136 million, including €8.5 million upfront, milestone payments totaling €127.5 million, and a double-digit percentage of net sales. The exclusivity term is 15 years post-commercial launch, with an automatic 2-year extension.

This move follows the 2024 BAT2506 (golimumab biosimilar) collaboration between the two companies, signaling a deepening strategic alliance in the biosimilar space. BAT1806 enters the market at a time when global tocilizumab sales remain strong (~€2.8 billion in 2024, with €700 million from Europe), highlighting a significant commercial opportunity despite increasing biosimilar competition.

For Bio‑Thera, BAT1806 strengthens its global footprint in high-value autoimmune therapies, building on its track record of FDA- and EMA-approved monoclonal antibodies including TOFIDENCE™ (tocilizumab), Avzivi® (bevacizumab biosimilar), and Usymro® (ustekinumab biosimilar). For STADA, the deal complements its growing biosimilar portfolio in immunology, leveraging established commercial infrastructure to capture market share in Europe and beyond.

Industry observers see the collaboration as part of a broader trend: Chinese biopharma increasingly leveraging domestic R&D and manufacturing capabilities to partner with established Western distributors, accelerating international market access for biosimilars. BAT1806’s rollout could provide more affordable access to tocilizumab therapy in multiple regions, while reinforcing Bio‑Thera’s strategy of focusing on immune-oncology and autoimmune portfolios.

Key takeaways:

• BAT1806 represents a clinically equivalent, lower-cost alternative to Actemra® for autoimmune conditions.
• The deal highlights Bio‑Thera’s maturing global business model, combining innovation with international licensing partnerships.
• STADA strengthens its European biosimilar commercial leadership, particularly in autoimmune therapies.
• The collaboration reflects the growing trend of China–Europe biosimilar partnerships, with potential lessons for other late-stage antibody programs.