Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderately to severely active ulcerative colitis. Bio-Thera Solutions reported that its clinical trial is a multicenter, randomized, double-blind, and parallel controlled study to compare the efficacy and safety of BAT2206 to Stelara® in moderately to severely psoriatic patients and is expected to enroll approximately 472 volunteers. Bio-Thera Solutions’ Founder and CEO, Dr. Shengfeng Li, commented that this is “Bio-Thera’s fourth biosimilar to enter a global phase III clinical study.” According to the press release, Bio-Thera is also developing several other biosimilars, including bevacizumab and tocilizumab, which have successfully completed global Phase III clinical trials, and pursuing biosimilar versions of golimumab, mepolizumab, and dupilumab.
Blog Big Molecule Watch July 21, 2021