Bio-Thera Solutions and STADA Arzneimittel have expanded their biosimilars collaboration to include tocilizumab, an immunomodulatory monoclonal antibody sold by Roche under the brand name RoActemra.
Tocilizumab is used for treating various inflammatory and autoimmune disorders.
Bio-Thera and STADA initially entered into a collaboration in May last year for BAT2506, the former’s biosimilar to Janssen’s Simponi (golimumab).
Under the expanded collaboration, Bio-Thera will oversee the development, production, and supply of the tocilizumab biosimilar.
STADA will manage its exclusive commercialisation in the European Union (EU), UK, Switzerland, and selected other regions.
The agreement for tocilizumab is pending shareholder approval.
Bio-Thera CEO Shengfeng Li 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.”
Based in Guangzhou, China, Bio-Thera is developing advanced therapies and biosimilars for cancer, autoimmune, cardiovascular, eye diseases, and others.
The company has over 20 candidates in clinical trials, with an emphasis on immuno-oncology and targeted therapies like antibody-drug conjugates.
Bio-Thera’s tocilizumab 20mg/ml concentrate, developed as BAT1806, received EU-wide marketing authorisation in June last year.
Also, the European Medicines Agency (EMA) has accepted the marketing authorisation application for its golimumab biosimilar, BAT2506.
STADA is a Germany-based pharmaceutical company providing generic medicine and speciality pharmaceuticals across more than 100 countries.
STADA global speciality head Ian Henshaw said: “With global RoActemra/Actemra sales in 2024 reported at approximately €2.8bn, including around $700m 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.”
Earlier this year, Bio-Thera signed an agreement with Dr. Reddy’s Laboratories to exclusively market its biosimilars, BAT2206 and BAT2506, in Southeast Asia.
Under the partnership, Bio-Thera will be responsible for the development, manufacturing, and supply of these biosimilars.
Dr. Reddy’s will manage regulatory approvals and commercial activities in countries including Cambodia, Indonesia, Malaysia, Thailand, the Philippines, and Vietnam.
