Blog Big Molecule Watch July 21, 2021

First Patient Dosed with Stelara® biosimilar in Bio-Thera Solutions’ Phase III Clinical Trial for Moderate to Severe Psoriasis

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.

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