16 August 2019 - - Chinese clinical-stage pharmaceutical company Bio-Thera Solutions has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2506, a proposed biosimilar of Simponi (golimumab), to EU-sourced Simponi in normal healthy volunteers, the company said.

The clinical study is a randomized, double-blind, two-arm, parallel group study that is expected to enroll approximately 182 healthy volunteers.

Each patient will receive a single subcutaneous dose of either BAT2506 or EU-sourced Simponi.

Bio-Thera Solutions is developing several additional proposed biosimilars, including biosimilar versions of Avastin and Actemra/RoActemra, which are both currently being evaluated in global Phase III clinical trials. Bio-Thera Solutions is also pursuing biosimilar versions of Humira and Stelara.

Bio-Thera Solutions, a 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.