Bio-Thera Solutions Ltd., a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi® (golimumab). 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 (PsA) patients that is expected to enroll approximately 480 volunteers. In the U.S., 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.
“Patient enrollment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study,” said Shengfeng Li, CEO, Bio-Thera Solutions. “Bio-Thera is focused on developing and commercializing a pipeline of safe, effective and affordable biosimilars and is proud to be one step closer to bringing a Simponi® biosimilar to patients around the world.”
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.
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