9 June 2021 - - China-based pharmaceutical company Bio-Thera Solutions, Ltd. (688177.SH) has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab), the company said.

The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2506 to Simponi in psoriatic arthritis patients that is expected to enroll approximately 480 volunteers.

In the US, Simponi is approved for active PsA alone, or in combination with methotrexate as well as moderately to severely active rheumatoid arthritis in combination with methotrexate, active ankylosing spondylitis and moderate to severe ulcerative colitis with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy.

Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials.

Bio-Thera Solutions is also pursuing biosimilar versions of ustekinumab, mepolizumab and dupilumab.

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical 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.

As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and one of which, QLETLI, a biosimilar to adalimumab, is available to patients in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, including differentiated and innovative anti-OX40, anti-TIGIT antibodies.