Biosimilars for the Treatment of PsoriasisA Systematic Review of Clinical Trials and Observational Studies

Question  What is the effectiveness and safety of biosimilars compared with originator biologics for the treatment of patients with psoriasis?

Findings  This systematic review of 14 randomized clinical trials and 3 cohort studies found that there was no clinically or statistically significant difference in efficacy and safety between biosimilars of adalimumab, etanercept, infliximab, ustekinumab, and originators for the treatment of patients with psoriasis. Overall, findings from 2 randomized clinical trials suggested that switching from adalimumab originator to BCD-057 and GP2017 reduced treatment efficacy, and 1 cohort study suggested that switching to GP2017 and SB5 was associated with more adverse effects; however, these differences were not clinically significant, and the certainty of evidence was low.

Meaning  Starting new patients on biosimilars or switching patients recieving originators to biosimilars could be considered to reduce treatment costs; future studies are needed to examine the long-term effectiveness and safety of biosimilars in clinical settings.

Importance  Biosimilars have the potential to reduce costs for the management of moderate-to-severe psoriasis compared with originators. However, the extrapolation of evidence enables the approval of a biosimilar for use in indications held by the originator without directly being studied in clinical trials. Thus, biosimilars can be approved for psoriasis based on extrapolated evidence from other diseases. The availability of evidence for the effectiveness and safety of biosimilars for the treatment of psoriasis is therefore unclear.

Objective  To compare the efficacy/effectiveness and safety of biosimilars with originator biologics for the treatment of patients with psoriasis.

Evidence Review  MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and The European Union Clinical Trials Register were searched in August 2022. Eligible studies were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. All analyses were conducted from September 2022 to November 2022.

Findings  Fourteen trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. Twelve trials compared biosimilars with originators in originator-naive patients (starters), and 11 trials compared switching from originator to biosimilar (switchers) with continuous originator treatments. There was no clinically or statistically significant difference in rates of achieving 75% improvement in Psoriasis Area and Severity Index scores and risks of adverse events (AEs) at week 16 and week 52 between the comparators. Two cohort studies showed no difference in effectiveness and safety outcomes between originators and biosimilars, whereas 1 study reported more AEs in patients who switched to biosimilars of adalimumab at 12 months. Three trials showed low risk of bias, whereas 11 trials had moderate risk of bias. All cohort studies had moderate to high risk of bias.

Conclusions and Relevance  In this systematic review, there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators for the treatment of patients with psoriasis. Most of the available evidence was based on randomized clinical trials, although high-quality real-world evidence was lacking. Future studies are needed to examine the long-term effectiveness and safety of biosimilars for the treatment of patients with psoriasis.