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

Table 2 Clinical scenarios and suggested approaches for biosimilar use in inflammatory bowel disease

Clinical scenario1	Risk profile	Suggested approach	Monitoring	Key considerations
Biologic-naive initiation	Generally low	Biosimilar as default first-line biologic on pharmacoeconomic grounds	Standard protocol (CRP, FCP at 4-6 weeks, 12-week, 6-month)	Lowest nocebo risk (no prior reference point). Cost savings most impactful at population level. Shared decision-making still recommended
Stable remission on originator	Low to moderate	Non-medical switch with structured communication (positive framing, one voice)	Standard protocol + clinical reassessment at 4-6 weeks	Highest nocebo risk. Communication quality is the key determinant of success. One voice strategy essential. Most extensively studied scenario (NOR-SWITCH, PROSIT-BIO)
Prior switching history	Moderate	Individualized assessment; consider TDM at baseline and 12 weeks	Enhanced: TDM + biomarkers at closer intervals	Prior immunogenicity signals may warrant proactive TDM. Distinguish prior pharmacological failure from nocebo-driven discontinuation before deciding approach
Complex disease (fistulizing CD, extensive colitis, EIM)	High	Caution advised; biosimilar initiation feasible but switching should be deferred during active disease	Enhanced: TDM + endoscopy/imaging as indicated	Treatment stability takes precedence over cost optimization. If switching, ensure that disease is in remission with objective confirmation before transition
Special populations (pregnancy, pediatric, postoperative)	High (context-dependent)	Defer switching; maintain current effective therapy. Biosimilar initiation in naive patients may be considered case-by-case	Standard + disease-specific monitoring	Limited data on switching during pregnancy or postoperative period. Stability and continuity of care are priorities. Pediatric data emerging but still limited

¹This table represents a pragmatic author-proposed framework and does not constitute formal guideline recommendations. Clinical judgment should be exercised for individual patients.

CD: Crohn’s disease; EIM: Extraintestinal manifestations; TDM: Therapeutic drug monitoring; CRP: C-reactive protein; FCP: Fecal calprotectin.