Biosimilar Switching in IBD: Safety, Efficacy, and Immunogenicity in 10,812 Patients � A Systematic Review and Meta-analysis
Bibliographic record
Abstract
BACKGROUND: Biosimilars of infliximab and adalimumab are increasingly adopted in inflammatory bowel disease (IBD) to reduce healthcare costs, but concerns persist regarding their long-term efficacy, immunogenicity, and safety post-switch. This meta-analysis synthesizes contemporary evidence on outcomes after transitioning from originators to biosimilars. METHODS: We systematically searched PubMed, Embase, MEDLINE, and conference abstracts (inception-June 2025) to identify randomized controlled trials (RCTs) and observational studies comparing biosimilars (CT-P13, SB2, SB5, etc.) with originators in IBD. Primary outcomes included clinical remission, discontinuation rate, adverse events (AEs), C-reactive protein (CRP), and fecal calprotectin (FCAL), and anti-drug antibody (ADA) incidence. Risk of bias was assessed using Cochrane and Newcastle-Ottawa tools. Pooled odds ratios (ORs) and event rates were calculated using random-effects models. RESULTS: Among 37 studies (36 observational, 1 RCTs) encompassing 10812 IBD patients, biosimilars demonstrated comparable clinical remission rates pre- and post-switch in Crohn's disease (CD) (OR = 0.87, 95% CI: 0.74-0.96) and ulcerative colitis (UC) (OR = 1.25, 95% CI: 0.83-1.90). Biomarkers (CRP, fecal calprotectin) remained stable post-transition. Pooled discontinuation rates were 13% (range: 2-36%) after switching. Safety profiles were similar between biosimilars and originators, ADA incidence (OR = 0.96, 95% CI: 0.46-2.02) showed no significant differences. Heterogeneity stemmed from differences in follow-up duration, disease subtype (CD vs. UC), and variable outcome definitions. CONCLUSION: Biosimilars maintain comparable efficacy, safety, and immunogenicity to originators in IBD, supporting their use in single or multiple switching scenarios. Standardized reporting of mucosal healing, drug monitoring, and economic metrics is critical to optimize biosimilar adoption in real-world practice.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.021 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.018 | 0.038 |
| Bibliometrics | 0.007 | 0.008 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".