GUANGZHOU, China--(BUSINESS WIRE)--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 BAT2506, a proposed biosimilar of Simponi® (golimumab), to EU-sourced Simponi® in normal healthy volunteers. 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®.
“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,” said Shengfeng Li, CEO, Bio-Thera Solutions. “Bio-Thera is committed to bringing safe and effective biosimilars to patients around the world.”
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®.
About Bio-Thera Solutions
Bio-Thera Solutions Ltd, a leading 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. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Simponi® is a registered trademark of Janssen Biotech, Inc
2 Avastin® is a registered trademark of Genentech, Inc
3 Actemra® is a registered trademark of Genentech, Inc
4 RoActemra® is a registered trademark of Genentech, Inc
5 Humira® is a registered trademark of Abbvie, Inc
6 Stelara® is a registered trademark of Janssen Biotech, Inc