Bio-Thera Begins Phase 1 Study of Proposed Golimumab Biosimilar

The Center for Biosimilars Staff

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

The study compares the pharmacokinetics and safety of BAT2506 to golimumab sourced from the European Union, with each participant receiving either a single subcutaneous dose of BAT2506 or golimumab. The randomized, double-blind, 2-arm, parallel group study is expected to enroll about 182 healthy volunteers.

“Initiating our [phase 1] clinical trial for BAT2506, our proposed biosimilar for Simponi, represents the fourth biosimilar that Bio-Thera has advanced into clinical trials,” said Shengfeng Li, chief executive office of Bio-Thera Solutions, in a statement. “Bio-Thera is committed to bringing safe and effective biosimilars to patients around the world.”

The brand-name Simponi, developed by Janssen, is FDA approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), and ulcerative colitis. An anti—tumor necrosis factor therapy, golimumab is administered via a subcutaneous injection. Another formulation of golimumab, sold as Simponi Aria, is available for intravenous infusion.

Worldwide, Janssen saw sales of $563 million from the 2 formulations of Simponi, up 2.7% from the same quarter in 2018.

Bio-Thera Solutions is also developing other proposed biosimilars. Its proposed adalimumab biosimilar, BAT1406, recently met its primary end point of equivalent efficacy to reference adalimumab, Humira, in a phase 3 trial conducted in patients with active AS.

It is also developing a proposed bevacizumab biosimilar, BAT1706, referencing Avastin, and BAT1806, a proposed tocilizumab (Actemra) biosimilar. BAT1806 is also in a phase 3 trial.