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News & Trends - Pharmaceuticals

Phase III trial commences for Janssen’s Stelara biosimilar

Health Industry Hub | July 21, 2021 |
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Pharma News: Bio-Thera Solutions, a commercial-stage pharmaceutical company in China, announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of human monoclonal antibody, Stelara (ustekinumab).

Indicated in the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease, Stelara pulled in USD$7.7 billion globally last year, a 21% increase from 2019 despite the pandemic’s impact on the market. 

The biosimilar clinical study will compare the efficacy and safety of BAT2206 to Stelara in moderately to severely psoriatic (PsO) patients that is expected to enrol approximately 472 volunteers.

Ustekinumab is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis, among many other autoimmune diseases.

“BAT2206 is Bio-Thera’s fourth biosimilar to enter a global phase III clinical study,” commented Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions.

“The advancement of BAT2206 into a global Phase III study demonstrates Bio-Thera’s continued commitment to developing biosimilars of important innovative drugs to expand patient access at lower costs.”

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 golimumab, mepolizumab and dupilumab.

In May 2021, BioFactura Australia also announced the initiation of a pivotal PK (pharmacokinetics) Phase 1 clinical trial for Stelara’s biosimilar (BFI-751).

The study progressed with the opening of three clinical sites in Adelaide and Brisbane, Australia, and Auckland, New Zealand, which are now accepting new volunteers for the trial.


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