ReviewFrontiers in pharmacology2026
Clinical evidence and implementation guidance for biosimilar switching in ankylosing spondylitis.
Review in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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0 citing papers in PubMed.
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Authors and funding
7 authors.
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Abstract
Biosimilar tumor necrosis factor inhibitors provide therapeutically equivalent alternatives to reference biologics for ankylosing spondylitis (AS) management at reduced costs. Clinical adoption depends on the confidence that switching stable patients from reference products to biosimilars maintains disease control. This review synthesizes the evidence on biosimilar switching in AS populations from regulatory approval programs, randomized controlled trials, and real-world observational studies. It is presented as a structured narrative review based on searches of PubMed, EMBASE, and the Cochrane Library, covering publications from January 2013 to March 2025. Approved biosimilars achieve molecular similarity and therapeutic equivalence to the reference products through analytical characterization, functional equivalence studies, and clinical comparability trials. Randomized switching trials demonstrate maintained efficacy and comparable safety profiles when patients with stable AS transition from the reference infliximab to biosimilar formulations. Immunogenicity profiles demonstrate equivalence between products. Multinational registry data corroborate these findings across diverse healthcare systems. Retention rates and disease activity outcomes are comparable between biosimilars and reference products when baseline patient characteristics are considered. Successful implementation requires patient engagement through transparent communication about biosimilar development and switching evidence. Individualized monitoring protocols should be tailored to baseline disease stability. Clinicians should recognize nocebo effects as a distinct contributor to switching outcomes and apply structured management strategies to address them. The accumulated evidence supports biosimilar switching as an appropriate clinical therapeutic strategy for AS patients with stable responses on reference biologics. This approach offers healthcare cost reductions without compromising treatment outcomes.
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