GUANGZHOU, China–(BUSINESS WIRE)–Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for its tocilizumab biosimilar, BAT1806. Bio-Thera’s Phase III clinical trial will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s RoActemra® 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 biosimilars,” said Shengfeng Li, CEO, Bio-Thera Solutions. “Bio-Thera is proud to bring an Actemra® biosimilar 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 biosimilars, including a biosimilar version of bevacizumab, which is currently being evaluated in a global Phase III clinical trial. Bio-Thera Solutions is also pursuing biosimilar versions of adalimumab, ustekinumab, secukinumab and golimumab, among others.
About Bio-Thera Solutions
Bio-Thera Solutions Ltd, a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Actemra® is a registered trademark of Genentech, Inc
2 RoActemra® is a registered trademark of Genentech, Inc