Bio-Thera and STADA have expanded their biosimilars collaboration, now encompassing the drug tocilizumab.
Bio-Thera Solutions, a leading innovative global biopharmaceutical company based in Guangzhou, China, and STADA Arzneimittel AG have announced an expansion of their biosimilars alliance. This expansion includes Tocilizumab, a targeted immunomodulatory monoclonal antibody, which is indicated for the treatment of various inflammatory and autoimmune diseases.
The agreement builds on an existing partnership on BAT2506, a biosimilar candidate for Simponi® (Golimumab). Bio-Thera will be responsible for the development, manufacturing, and supply of the biosimilar to the reference product RoActemra® of Roche.
The marketing authorization application (MAA) for BAT2506 was accepted by the European Medicines Agency. Bio-Thera's BAT1806-developed Tocilizumab 20 mg/ml concentrate for preparing an injection solution received EU-wide approval in June 2024.
STADA will obtain the exclusive rights to commercialize the product in the EU, UK, Switzerland, and selected other countries under its own marketing authorization. This biosimilar can be used as a treatment for various arthritic conditions.
The effectiveness of the agreement on Tocilizumab is subject to shareholder approval. The forward-looking statements in the news release involve known and unknown risks and uncertainties. These include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations.
Other risks and uncertainties include factors that could cause actual results to differ from those presented. These factors include risks and uncertainties inherent in pharmaceutical research and development. The forward-looking statements are not guarantees of future performance or developments.
Bio-Thera Solutions is committed to researching and developing novel therapeutics for various diseases and biosimilars. The CEO of Bio-Thera during the expansion of the Biosimilars alliance to include tocilizumab is Shengfeng Li.
The announcement is not intended for publication or distribution in the United States. Actual results and events may differ materially from information contained in the forward-looking statements. Bio-Thera Solutions has issued a cautionary note regarding forward-looking statements in the news release.
As of December 31, 2024, STADA Arzneimittel AG employed 11,649 people worldwide. Global sales of RoActemra/Actemra reached around 2.8 billion euros in 2024, including around 700 million euros in Europe despite the entry of biosimilar competitors.
