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^?.