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 biosesesimilar 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 biosesesimilar for Actemra^®, is an important step for Bio-Thera as we work to develop and commercialize safe and effective biosesesimilars in China, the EU, the US and the rest of the world,” said Shengfeng Li, CEO, Bio-Thera Solutions.  “Biosesesimilars will provide increased access to important therapeutics to patients around the world.”

Bio-Thera Solutions is developing several additional proposed biosesesimilars, including a biosesesimilar version of Avastin^®, which is currently being evalssuated in a global Phase III clinical trial.  Bio-Thera Solutions is also pursuing biosesesimilar versions of Humira^®, Stelara^®, Cosentyx^® and Simponi^®.