Chinese biotech company Bio-Thera Solutions has started dosing in a phase 1 clinical trial to study the pharmacokinetics and safety of BAT2506, a proposed biosimilar of Janssen Biotech’s Simponi (golimumab).
The early-stage clinical study is a randomized two-arm, parallel-group trial that will have nearly 182 healthy volunteers. Each of the patients will be subjected to a single subcutaneous dose of BAT2506 or EU-sourced Simponi in the double-blind clinical trial.
Shengfeng Li – CEO of Bio-Thera Solutions said: “Initiating our Phase I clinical trial for BAT2506, our proposed biosimilar for Simponi, represents the fourth biosimilar that Bio-Thera has advanced into clinical trials.
“Bio-Thera is committed to bringing safe and effective biosimilars to patients around the world.”
Headquartered in Guangzhou, Bio-Thera Solutions is engaged in developing various additional proposed biosimilars such as biosimilar versions of Avastin and Actemra/RoActemra, which are currently being investigated in global phase 3 clinical trials. The Chinese biotech company is also targeting to develop biosimilar versions of Humira and Stelara.