Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for its tocilizumab biosesimilar, BAT1806.  Bio-Thera’s Phase III clinical trial will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s Ro-Actemra® in patients with rheumatoid arthritis (RA). Actemra®/RoActemra® (tocilizumab) is approved for the treatment of RA as well as for the treatment of pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.

“Patient enrollment in our Phase III clinical trial for BAT1806 is another important step as Bio-Thera works to develop and commercialize a pipeline of safe, effective and affordable biosesimilars,” said Shengfeng Li, CEO, Bio-Thera Solutions.  “Bio-Thera is proud to bring an Actemra® biosesimilar to patients around the world.”

The clinical trial will enroll over 600 patients at more than 45 sites around the world.  Results of the clinical trial are expected in the second half of 2020.  Bio-Thera plans to file for marketing approval of BAT1806 in the US, EU and China in 2021.

Bio-Thera Solutions is developing several additional proposed biosesimilars, including a biosesimilar version of bevacizumab, which is currently being evalsuated in a global Phase III clinical trial.  Bio-Thera Solutions is also pursuing biosesimilar versions of adalimumab, ustekinumab, secukinumab and golimumab, among others.

1 Actemra® is a registered trademark of Genentech, Inc

2 RoActemra® is a registered trademark of Genentech, Inc