July 25, 2018-- Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1806, a proposed biosimilar of Actemra® (tocilizumab), to US-sourced Actemra® and EU-sourced RoActemra® in normal healthy volunteers. The clinical study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 130 healthy volunteers.
“Initiating our Phase I clinical trial for BAT1806, our proposed biosimilar for Actemra®, is an important step for Bio-Thera as we work to develop and commercialize safe and effective biosimilars in China, the EU, the US and the rest of the world,” said Shengfeng Li, CEO, Bio-Thera Solutions. “Biosimilars will provide increased access to important therapeutics to patients around the world.”
Bio-Thera Solutions is developing several additional proposed biosimilars, including a biosimilar version of Avastin®, which is currently being evaluated in a global Phase III clinical trial. Bio-Thera Solutions is also pursuing biosimilar versions of Humira®, Stelara®, Cosentyx® and Simponi®.
