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<p>The recent introduction of ustekinumab biosimilars represents a pivotal advancement in the management of inflammatory bowel disease (IBD), offering opportunities to enhance access to advanced therapy and reduce healthcare costs without compromising treatment efficacy. IBD, encompassing Crohn’s disease and ulcerative colitis, imposes a substantial economic burden on patients and the health care system, with biologics driving most direct costs. Biosimilars have successfully reduced expenditures across various therapeutic classes, notably anti-tumor necrosis factor agents, and now extend these benefits to interleukin-12/23 inhibitors. This review summarizes the regulatory, clinical, and practical considerations for integrating ustekinumab biosimilars into IBD care in the United States. Food and Drug Administration approval is based on rigorous totality-of-evidence evaluations, leveraging pharmacokinetic, immunogenicity, and efficacy studies in sensitive populations such as moderate-to-severe plaque psoriasis, with regulatory extrapolation to IBD indications. Clinical trials of eight ustekinumab biosimilars have consistently demonstrated therapeutic equivalence, including maintenance of efficacy and safety following single or multiple switches from the reference product. Implementation in IBD practice requires careful navigation of operational and patient-centered challenges. Key considerations include coordination of intravenous induction and subcutaneous maintenance therapy across medical and pharmacy benefits, product-specific storage and device differences, and proactive mitigation of the nocebo effect through shared decision making and structured patient education. Ustekinumab biosimilars are poised to expand therapeutic accessibility and support healthcare cost containment. Successful adoption will depend on clinician familiarity, streamlined operational workflows, and patient-centered strategies to maintain confidence, minimize treatment disruption, and optimize long-term outcomes in IBD management.</p>

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Integration of Ustekinumab Biosimilars into Inflammatory Bowel Disease Care: Evidence, Implementation, and Patient-Centered Considerations

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月18日

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  • Shannon L. Piche,
  • Michelle D. Becker,
  • Shubha Bhat,
  • Linda L. Huang,
  • Sunanda V. Kane

摘要

The recent introduction of ustekinumab biosimilars represents a pivotal advancement in the management of inflammatory bowel disease (IBD), offering opportunities to enhance access to advanced therapy and reduce healthcare costs without compromising treatment efficacy. IBD, encompassing Crohn’s disease and ulcerative colitis, imposes a substantial economic burden on patients and the health care system, with biologics driving most direct costs. Biosimilars have successfully reduced expenditures across various therapeutic classes, notably anti-tumor necrosis factor agents, and now extend these benefits to interleukin-12/23 inhibitors. This review summarizes the regulatory, clinical, and practical considerations for integrating ustekinumab biosimilars into IBD care in the United States. Food and Drug Administration approval is based on rigorous totality-of-evidence evaluations, leveraging pharmacokinetic, immunogenicity, and efficacy studies in sensitive populations such as moderate-to-severe plaque psoriasis, with regulatory extrapolation to IBD indications. Clinical trials of eight ustekinumab biosimilars have consistently demonstrated therapeutic equivalence, including maintenance of efficacy and safety following single or multiple switches from the reference product. Implementation in IBD practice requires careful navigation of operational and patient-centered challenges. Key considerations include coordination of intravenous induction and subcutaneous maintenance therapy across medical and pharmacy benefits, product-specific storage and device differences, and proactive mitigation of the nocebo effect through shared decision making and structured patient education. Ustekinumab biosimilars are poised to expand therapeutic accessibility and support healthcare cost containment. Successful adoption will depend on clinician familiarity, streamlined operational workflows, and patient-centered strategies to maintain confidence, minimize treatment disruption, and optimize long-term outcomes in IBD management.