Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

July 26, 2018 |

2 min read

The clinical study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 130 healthy volunteers.

GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd., 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^®.

About Bio-Thera Solutions

Bio-Thera Solutions Ltd, a leading global 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 Actemra^® is a registered trademark of Genentech, Inc
2 RoActemra^® is a registered trademark of Genentech, Inc
3 Avastin^® is a registered trademark of Genentech, Inc
4 Humira^® is a registered trademark of Abbvie, Inc
5 Stelara^® is a registered trademark of Janssen Biotech, Inc
6 Cosentyx^® is a registered trademark of Novartis Pharmaceuticals Corporation
7 Simponi^® is a registered trademark of Janssen Biotech, Inc