Pyzchiva (ustekinumab-ttwe): A New Biosimilar for Psoriasis

The objective of the study is to analyze the pharmacology, efficacy, and safety of ustekinumab-ttwe in the treatment of moderate-to-severe plaque psoriasis.

PubMed, Embase, and ClinicalTrials.gov were searched using the following search terms: ustekinumab, biosimilar, ustekinumab-ttwe, Pyzchiva, SB17, and psoriasis.

Articles published in English between January 9, 2015, and June 21, 2025, related to the pharmacology, pharmacokinetics, efficacy, safety, immunogenicity, and clinical trials were reviewed.

Search results from PubMed and EMBASE yielded 259 articles, and 12 studies from Clinicaltrials.gov. Only 2 clinical trials of ustekinumb-ttwe's use in psoriasis were identified and were included in analysis. The pharmacokinetic parameters of ustekinumab-ttwe (SB17), European Union-sourced ustekinumab (EU-UST) and United States-sourced ustekinumab (US-UST) were similar in its phase I trial. In addition, a phase III trial comparing the efficacy of ustekinumab-ttwe to ustekinumab showed that the difference of percent change from baseline of the Psoriasis Area and Severity Index (PASI) score between the 2 groups was comparable with a change of 85.7% for ustekinumab-ttwe (95% confidence interval [CI] = [-3.78, 2,58]) and 86.4% for ustekinumab (90% CI = [-3.34, 1.93]).Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:The pharmacology, pharmacokinetics, efficacy, safety, and immunogenicity of ustekinumab-ttwe and reference ustekinumab were equivalent, demonstrating its role as a biosimilar. There are no current clinical trials directly comparing ustekinumab-ttwe with ustekinumab's other biosimilars.

Ustekinumab-ttwe's equivalence to its reference biologic ustekinumab creates another treatment option for patients with moderate- to- severe plaque psoriasis.