Commission commences process outlined in Article 18 (2) of Regulation (EC) 1107/2009.
In a significant move, STADA Arzneimittel AG and Bio-Thera Solutions, Ltd. have announced an expansion of their biosimilars partnership. This collaboration will focus on the development, manufacturing, and commercialization of a biosimilar to Roche's RoActemra® reference product, known as Tocilizumab.
Bio-Thera Solutions, a leading biopharmaceutical company based in Guangzhou, China, will be responsible for the production and supply of the biosimilar. Their expertise in developing and manufacturing biologic medicines makes them an appealing partner for STADA.
The marketing authorization for the biosimilar, BAT1806, was issued by the European Medicines Agency (EMA) following a positive opinion. This authorization is valid throughout the EU for the vials developed by Bio-Thera. STADA will have exclusive rights to commercialize BAT1806 under its own marketing authorization in the EU, UK, Switzerland, and selected other countries, including Turkey, Israel, and Russia.
The effectiveness of the agreement covering Tocilizumab is subject to shareholder approval. However, the partnership represents an attractive opportunity to broaden patient access to biological treatments and grow STADA's immunology portfolio.
Tocilizumab, the active ingredient in BAT1806, is a targeted immunomodulatory monoclonal antibody used to treat inflammatory and autoimmune disorders. In 2024, global sales of RoActemra/Actemra, the reference product, were approximately €2.8 billion, including around US$700 million in Europe. This underscores the market potential for the biosimilar.
This agreement builds upon an existing partnership on similar terms for BAT2506, a biosimilar candidate to Simponi® (golimumab). STADA, a German-based pharmaceutical company with a three-pillar strategy consisting of consumer healthcare products, generics, and specialty pharma, sells products in over 100 countries worldwide.
The marketing authorization for BAT1806 is a significant milestone in the partnership between STADA and Bio-Thera Solutions. Both companies look forward to bringing this important treatment option to patients in the EU, UK, Switzerland, and other selected countries.
Read also:
- Understanding Hemorrhagic Gastroenteritis: Key Facts
- Stopping Osteoporosis Treatment: Timeline Considerations
- Tobacco industry's suggested changes on a legislative modification are disregarded by health journalists
- Expanded Community Health Involvement by CK Birla Hospitals, Jaipur, Maintained Through Consistent Outreach Programs Across Rajasthan
%20of%20Regulation%20(EC)%201107%2F2009.){kind=link}