Comparative Efficacy and Safety of Ustekinumab Biosimilars versus Reference Products in Plaque PsoriasisUstekinumab biosimilars show similar results to the original drug

Clinical drug investigation Published October 1, 2026 Study authors: Rashid Mohsin, Muhammad Awon, Saeed Eeraj, Qureshi Ali Akram, Mubashir Mohammad Maheer, Waqas Bin Wa… PubMed ↗ DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Ustekinumab biosimilars demonstrate comparable efficacy and safety to the reference product in patients with plaque psoriasis.

This meta-analysis evaluates the clinical equivalence of ustekinumab biosimilars compared to the reference product in patients diagnosed with moderate-to-severe plaque psoriasis. By analyzing data from a large cohort of 4,532 patients, the study aims to provide clinicians with evidence-based insights into the interchangeability of these biologics. The primary endpoint focused on the mean percent change in the Psoriasis Area and Severity Index (PASI) at 12 weeks, a standard metric for assessing rapid clinical response in dermatological conditions.

The primary outcome analysis revealed no statistically significant difference between the biosimilars and the reference product at the 12-week mark (MD 0.44; 95% CI -0.99 to 1.88, p = 0.54). This suggests that patients switched to or initiated on a biosimilar can expect a similar rate of initial clearance. Furthermore, while some statistically significant differences were noted in PASI and Dermatology Life Quality Index (DLQI) scores at 28 weeks, these variations were deemed clinically insignificant, supporting the overall parity of the two treatment modalities.

Safety profiles were similarly comparable between the groups. The incidence of treatment-related adverse events (TRAEs) did not differ significantly between the biosimilar and reference products. This consistency is vital for clinical practice, as it suggests that switching patients to a biosimilar does not compromise the safety profile established by the original biologic. The data reinforces the confidence of practitioners in prescribing biosimilars as a reliable alternative for managing chronic inflammatory skin conditions.

One notable finding involved the presence of anti-drug antibodies (ADAs). The analysis showed a statistically significant lower risk of developing ADAs in patients treated with biosimilars (RR 0.68; 95% CI 0.55-0.85; p = 0.0005). However, it is critical to note that this finding was associated with substantial heterogeneity (I = 71%) and was categorized as very low-certainty evidence. Therefore, while the numerical difference exists, the clinical certainty regarding this specific outcome is limited.

Several limitations must be considered when interpreting these results. The study included a relatively short follow-up period of up to 52 weeks, which may not capture long-term durability of response or late-emerging adverse events. Additionally, all included trials were industry-funded, which may introduce potential bias in the reported outcomes. Despite these limitations, the core findings support the use of ustekinumab biosimilars as a viable and effective option for patients with plaque psoriasis.

In conclusion, the evidence suggests that ustekinumab biosimilars provide a therapeutic profile comparable to the reference product in both efficacy and safety. For clinicians managing moderate-to-severe plaque psoriasis, these findings support the integration of biosimilars into treatment regimens. The lack of significant differences in PASI and DLQI scores indicates that patients can achieve comparable clinical outcomes and quality of life improvements regardless of whether they receive the reference product or a biosimilar.

How this fits prior evidence

This meta-analysis confirms that ustekinumab biosimilars provide a comparable therapeutic profile to the reference product in terms of efficacy and safety. This supports the established use of ustekinumab in plaque psoriasis, which is a well-documented treatment for this condition. While other agents like guselkumab, secukinumab, and brodalumab rank highly for PASI 75 and PASI 90, this evidence specifically reinforces the reliability of the ustekinumab class, including its biosimilar counterparts, for managing moderate-to-severe plaque psoriasis.

Living with moderate to severe plaque psoriasis can be incredibly taxing. It is not just about the physical discomfort of itchy, inflamed skin; it is about the impact on a person's daily confidence and quality of life. For many, the drug ustekinumab has become a vital tool in managing these symptoms. Because of the high cost of original medications, many people and doctors look toward biosimilars. These are high-quality, similar versions of the original drug that are designed to provide the same benefits.

To see if these versions could truly replace the original, researchers looked at data from 4,532 patients. They compared people taking the ustekinumab biosimilars against those taking the original ustekinumab. They measured several things, including the severity of the skin symptoms and how the patients felt about their quality of life over a period of up to 52 weeks.

The results showed that the biosimilars performed very similarly to the original drug. At the 12-week mark, there was no significant difference in how well the skin cleared. While there were some tiny statistical differences at 28 weeks regarding skin scores and quality of life, these differences were so small that they were not considered meaningful in a real-world clinical setting. In other words, patients taking the biosimilar did not see a noticeable difference in their results compared to those on the original.

Regarding safety, the study found no significant differences in side effects between the two versions. There was one specific finding regarding anti-drug antibodies, which are proteins the body makes to fight off a medication. The study found a lower risk of these antibodies in the biosimilar group, but the researchers noted that this specific finding came from very low-certainty evidence and had a lot of variation in the data.

It is important to keep a few things in mind before making big changes. This study was funded by the industry, and the follow-up period was relatively short, lasting less than a year. Because of these factors, and the low certainty of the antibody data, this single study should not be seen as a final word. However, it does provide a helpful look at how these newer versions compare to the original.

For patients right now, this means that if you are considering a biosimilar for your psoriasis, the data suggests it can offer a similar experience to the original drug. You can talk to your doctor about whether a biosimilar is a good fit for your specific treatment plan.

What this means for you:

Ustekinumab biosimilars show similar effectiveness and safety to the original drug for moderate to severe psoriasis.

Study Details

Study typeMeta analysis

Sample sizen = 4,532

EvidenceLevel 1

Follow-up2.8 mo

PublishedOct 2026

PMID42584528

View Original Abstract ↓

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic, debilitating disease affecting 1-3% of the global population. Ustekinumab has been established as an effective therapy for moderate-to-severe plaque psoriasis, but its high cost limits patient access. Biosimilars offer a promising avenue to reduce costs and improve availability. Therefore, this study aimed to assess the efficacy, safety, and immunogenicity of biosimilars in comparison with ustekinumab. METHODS: We comprehensively searched PubMed, Cochrane Library, Embase, and clinical trial registries from their inception through August 2025 for phase III randomized controlled trials (RCTs) that directly compared ustekinumab biosimilars with the reference product in patients with moderate-to-severe plaque psoriasis. Data on efficacy, safety, and immunogenicity were extracted. The primary outcome was the mean percent change in Psoriasis Area and Severity Index (PASI) from baseline at 12 weeks. Secondary outcomes included mean percent change in PASI from baseline at 28 and 52 weeks, mean change in Dermatology Life Quality Index (DLQI) score from baseline at 12 and 28 weeks, proportion of participants achieving a Physician's Global Assessment (PGA) score of 0 or 1 at 12 and 28 weeks, proportion of participants developing anti-drug antibodies (ADAs), and proportion of participants experiencing treatment-related adverse events (TRAEs). Risk ratios (RRs) and mean differences (MDs) were calculated using the random-effects models. RESULTS: The meta-analysis included nine RCTs reported across ten studies (nine publications and one trial registry record). Nine RCTs (n = 4,532 total; n = 2,169 experimental; n = 2,363 control) contributed data on the primary outcome. The pooled mean difference (MD) was 0.44 (95% CI - 0.99 to 1.88, p = 0.54), indicating no statistically significant difference in PASI at 12 weeks between biosimilars and ustekinumab. Across all efficacy and safety outcomes, biosimilars demonstrated no statistically significant differences from ustekinumab except for three outcomes: the mean percent change in PASI at 28 weeks, the mean change in DLQI score at 28 weeks, and the presence of ADAs. Although the differences in PASI and DLQI at 28 weeks reached statistical significance, they were not considered clinically meaningful. For ADA development, the pooled RR was 0.68 (95% CI 0.55-0.85; p = 0.0005). However, this finding was associated with substantial heterogeneity (I = 71%) and very low-certainty evidence, warranting cautious interpretation. Additionally, the relatively short follow-up duration (≤ 52 weeks) and industry funding of all included trials are important limitations of this review. CONCLUSION: Ustekinumab biosimilars demonstrated no clinically meaningful differences across the outcomes and sustained comparable efficacy across all time points. These findings suggest that ustekinumab biosimilars offer a therapeutic profile comparable in safety and efficacy to that of the originator, providing evidence in favour of their adoption, which may result in wider patient access to biologics and reduced healthcare costs. PROSPERO: CRD420251133225.

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