Biosimilars in inflammatory bowel disease: Beyond evidence, toward trust and implementation

Table 3 Comparison of biosimilar adoption challenges: High-income vs resource-limited settings

Factor	High-income setting	Resource-limited setting1
TDM availability	Routine and proactive; integrated into standard switching protocols	Limited or unavailable in most centers; reliance on clinical assessment alone[58]
Consultation time	15-30 minutes; dedicated IBD clinics with multidisciplinary teams	5-10 minutes; general GI outpatient setting without dedicated IBD infrastructure[37]
Patient education resources	Nurse-led programs, digital tools, IBD helplines, patient associations	Limited; no dedicated IBD nurse specialist role in most settings[59]
Fecal calprotectin access	Standard of care; point-of-care testing increasingly available	Often unavailable or unaffordable; not routinely reimbursed[58]
Physician biosimilar training	Integrated into CME; supported by peer networks and professional societies	Variable; limited formal exposure; knowledge gaps regarding extrapolation and interchangeability[63]
Reimbursement structure	Established biosimilar incentive programs; gainsharing models	Restricted formularies; predominantly out-of-pocket payment; biosimilar-specific incentives rare[61]
Switching policy framework	Structured programs with shared decision-making; institutional protocols	Often policy-driven without concomitant communication support or monitoring infrastructure[12]
Nocebo risk environment	Moderate; mitigated by dedicated stewardship programs and infrastructure	High; structural amplification due to convergence of short consultations, low health literacy, social media misinformation, and low baseline trust[12,37]

¹Reference numbers correspond to the manuscript reference list. This comparison is intended to highlight structural differences that may influence biosimilar adoption outcomes; it does not imply that resource-limited settings are uniformly disadvantaged across all domains.

TDM: Therapeutic drug monitoring; CME: Continuing medical education; GI: Gastroenterology; IBD: Inflammatory bowel disease.