Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for Tocilizumab Biosimilar

Earlier this week, Bio-Thera Solutions announced the initiation of the Phase III clinical study for its tocilizumab biosimilar, BAT1806.  According to the press release, the Phase III clinical study will enroll over 65 patients at more than 45 sites around the world, and will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s RoActemra® in patients with rheumatoid arthritis.  Bio-Thera Solutions further stated that it expects results of the clinical trial in the second half of 2020 and that it plans to file for marketing approval of BAT1806 in the US, EU and China in 2021.