Tocilizumab biosimilar by Bio-Thera Solutions for Rheumatoid Arthritis: Likelihood of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tocilizumab biosimilar overview

Tocilizumab (Shiruili) is a humanized monoclonal antibody, that acts as immunosuppressant preparation. It is formulated as injectable solution for intravenous route of administration. Sirelin is indicated for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS).

Tocilizumab biosimilar (BAT-1806) is under development for the treatment of autoimmune diseases such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis (PJIA). The drug candidate is a biosimilar, anti-IL-6R antibody that targets Interleukin 6 Receptor (IL6R). The drug candidate is administered through intravenous route.

Bio-Thera Solutions overview

Bio-Thera Solutions (Bio-Thera) is a clinical-stage biopharmaceutical company that carries out the research and development, production of innovative drugs and biosimilars. The company’s pipeline products include humanized monoclonal antibodies and peptide drugs such as BAT8001, BAT8003, BAT1306, BAT2094, and BAT4306F. It also offers BAT1406, an adalimumab biosimilar; BAT1706, a bevacizumab biosimilar; BAT1806, a tocilizumab biosimilar; and BAT2506. Bio-Thera develops its products and therapies for the treatment of indications such as cancer, autoimmune diseases, cardiovascular diseases, arthritis, Crohn’s disease, psoriasis, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). The company operates a research and development center, manufacturing, and clinical facility in China. Bio-Thera is headquartered in Guangzhou, Guangdong, China.

For a complete picture of Tocilizumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.