Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and STADA Arzneimittel AG have agreed to extend their biosimilars alliance to cover tocilizumab, an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions.

As part of the agreement, 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 commercialise the biosimilar in the European Union (EU), the UK, Switzerland and selected other countries under its own marketing authorisation.

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

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

STADA's head of Global Specialty, Ian Henshaw remarked, "With global RoActemra/Actemra sales in 2024 reported at approximately EUR 2.8 billion, including around USD 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.”

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. 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.