Navigating the Transition: A Scoping Review of System-Level Factors in Biosimilar Integration for Immune-Mediated Inflammatory Diseases

Patients with immune-mediated inflammatory diseases are routinely transitioned from originator biologics to biosimilars to reduce healthcare costs. While barriers related to patient and practitioner beliefs and knowledge are well-documented, less focus has been placed on system-level factors that may hinder biosimilar uptake. This review aims to identify system-level factors that impact biosimilar brand transitions for treatment of immune-mediated inflammatory diseases, as reported by key stakeholders involved in real-world brand changes. A scoping review was conducted following the Arksey and O'Malley framework and was reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping reviews (PRISMA-ScR). A comprehensive search was performed in APA PsycInfo, Embase, PubMed, Scopus, and Web of Science, and databases for major conferences in rheumatology, dermatology, and gastroenterology. Data from relevant studies were extracted and summarized onto a structured coding sheet before being synthesized. Of 2301 articles screened, 47 journal articles and five conference abstracts were included. Most studies were conducted in the United States and focused primarily on rheumatology. Barriers and facilitators were organized into four overarching themes. These were regulatory and approval processes (e.g., tendering practices, interchangeability policies, prescriber guidelines), healthcare system policies and incentives (including quotas, insurance coverage, reimbursement mechanisms, and rebates), infrastructure and logistics (such as supply chain considerations and storage requirements), and communication and education (including media and expert influence and the involvement of patient organizations). Multiple components of the healthcare system play a role in successful biosimilar transitions. Leveraging regulations, policies, infrastructure, and communication before, during, and after transition offers a practical blueprint for managing brand changes across health systems and therapies.