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

Table 1 Key evidence supporting biosimilars in inflammatory bowel disease

Ref.	Design	Population	Agent	Key finding	Clinical relevance	Contextual interpretation1
Jørgensen et al[13], 2017	RCT, double-blind, non-inferiority	482, IMDs including IBD	CT-P13 (IFX)	Non-inferior: Disease worsening 26% (originator) vs 30% (switch)	First RCT-level evidence that a single switch does not compromise outcomes	A pivotal trial, though IBD subgroup was underpowered. Provides reassurance for switching in stable patients but does not address biologic-naive initiation or multiple switches
Ye et al[14], 2019	RCT, double-blind, phase 3	220, biologic-naive CD	CT-P13 (IFX)	Comparable clinical response and remission at weeks 6 and 30	First IBD-specific RCT confirming biosimilar efficacy in naive CD	Provided IBD-specific randomized evidence that helped reduce concerns about extrapolation from non-IBD indications
Fiorino et al[16], 2017; Armuzzi et al[17], 2019	Prospective multicenter cohort	810 (initial cohort 547), IBD, Italy	CT-P13 (IFX)	Response: 73.7% naive, 78.9% switch at 24 weeks; 71% biologic-naive at 12 months	Largest prospective European biosimilar IBD cohort	Demonstrated real-world effectiveness across naive, pre-exposed, and switched patients. Response rates were broadly consistent with historical originator data, providing supportive real-world context for biosimilar use
Barberio et al[18], 2021	Propensity score-weighted	IBD cohort	ABP501, SB5 (ADA)	Comparable remission maintenance vs originator ADA	Extended biosimilar evidence beyond IFX to ADA	Methodologically valuable for using propensity-score weighting to reduce selection bias. It also extends the evidence base to adalimumab biosimilars, an increasingly relevant class in routine practice
Moura et al[19], 2026	Retrospective registry	Canadian IBD, multiple biosimilars	Multiple (IFX, ADA)	No significant difference in remission, hospitalizations, or ED visits	Real-world Canadian data supporting biosimilar initiation	Notably addresses initiation (not only switching). Observational design limits causal inference, but the breadth of outcomes measured strengthens clinical applicability
Komaki et al[15], 2017	Systematic review and meta-analysis	IBD, CT-P13 studies	CT-P13 (IFX)	Equivalent efficacy and safety across pooled studies	Systematic synthesis of early biosimilar IBD data	Did not identify a clear signal of inferiority across heterogeneous studies. Useful for clinicians seeking a summary-level evidence assessment, though limited by the quality of included studies
Kritzinger et al[23], 2025	Retrospective observational cohort	81, IBD (85.2% CD), Canada (McGill)	Ustekinumab biosimilar (non-medical switch from originator)	Complete response stable: 87%, 85.9%, 84.3%, 92.7% (week 8 before switch, baseline, week 12, week 24, not significant). Drug sustainability 96.3% at 12 weeks, 95% at 24 weeks. Discontinuation 4.9%	First real-world ustekinumab biosimilar switching data in IBD	Extends biosimilar evidence beyond anti-TNF therapy to the IL-12/23 pathway. The high short-term persistence observed despite substantial prior biologic exposure supports the feasibility of ustekinumab biosimilar switching, although longer-term data remain needed

¹The “contextual interpretation” column reflects the authors’ assessment and does not represent formal guideline recommendations.

RCT: Randomized controlled trial; IMDs: Immune-mediated diseases; IBD: Inflammatory bowel disease; CD: Crohn’s disease; IFX: Infliximab; ADA: Adalimumab; ED: Emergency department; TNF: Tumor necrosis factor; IL: Interleukin.