A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab). The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and had comparable pharmacokinetic, safety and immunogenicity profiles to Stelara®.
In April 2023, Celltrion filed an application in Australia seeking approval of CT-P43 for all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.