Immune-Mediated Inflammatory Diseases: Addressing Safety Concerns and Enhancing the Accessibility of Biosimilars

Immune-mediated inflammatory diseases (IMIDs), including psoriasis, lupus, multiple sclerosis, and inflammatory bowel disease, are chronic conditions characterized by immune dysregulation and excessive inflammatory cytokine expression. Biologic therapies have transformed IMID management, and the introduction of biosimilars has improved treatment accessibility by reducing costs and alleviating the burden on healthcare systems. Despite regulatory approval and demonstration of similarity to reference biologics, biosimilar adoption remains limited due to uncertainties regarding interchangeability and extrapolation, insufficient communication among stakeholders, and the nocebo effect that influences patient and physician confidence. Although regulatory agencies provide detailed guidance and European Public Assessment Reports, regulatory and perceptual barriers persist in clinical practice. This work reviews real-world and clinical trial data on switching from reference biologics to biosimilars in IMIDs and demonstrates comparable safety and efficacy outcomes. However, patient perceptions and communication strategies significantly influence treatment success. Despite the available evidence, negative perceptions and a lack of confidence persist among both patients and healthcare professionals. Promoting understanding and confidence in biosimilars can increase access and availability and, consequently, enhance the benefits associated with their wider use. Therefore, addressing educational, regulatory, and clinical practice gaps is essential for optimizing biosimilar integration in IMID management.