SynthesisAlimentary pharmacology & therapeutics2019
Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.
Synthesis in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 7 syntheses or guidelines pooled it, 80 citations in OpenAlex.
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Pooled it
- Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.PloS one · 2023Pooled it
- Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018.Advances in therapy · 2022Pooled it
- Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease.Digestive diseases and sciences · 2020Pooled it
- Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Alimentary pharmacology & therapeutics · 2019Pooled it
- Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country.Frontiers in pharmacology · 2019Pooled it
- Relapse of retinal vasculitis after a non-medical biosimilar switch: a case report.Journal of ophthalmic inflammation and infection · 2026Article
- Breaking Barriers: Essential Reforms for a Competitive and Affordable Biosimilars Market.Current rheumatology reports · 2025Review
- Public deliberation to assess patient views on biosimilar medication switching for the treatment of inflammatory bowel disease.BMC health services research · 2024Article
- An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024Article
- Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients.Crohn's & colitis 360 · 2022Article
- Comparative effectiveness of second-line biological therapies for ulcerative colitis and Crohn's disease in patients with prior failure of anti-tumour necrosis factor treatment.BMC gastroenterology · 2022Article
- Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases.Therapeutic advances in musculoskeletal disease · 2022Article
- Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022Article
- A case report of drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn's disease.Therapeutic advances in drug safety · 2022Article
- Review
- Development of pulmonary sarcoidosis in Crohn's disease patient under infliximab biosimilar treatment after long-term original infliximab treatment: a case report and literature review.BMC gastroenterology · 2021Review
- Post-marketing analysis for biosimilar CT-P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan.Journal of gastroenterology and hepatology · 2021Article
- The Great Debate With IBD Biosimilars: Con: Biosimilars Should Not Be Routinely Used as a First Line Biologic and Not Switched From Reference Biologics.Crohn's & colitis 360 · 2021Review
Corrections and comments
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Authors and funding
4 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundBiosimilar versions of widely prescribed drugs, including the tumour-necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non-inferior to a reference product after multiple switches between products.
aimsTo investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
methodsPublished studies presenting data on switching between reference and biosimilar infliximab were identified by searching the MEDLINE database. Congress abstracts were identified by searching the EMBASE database and manually searching abstracts from relevant congresses.
resultsA total of 113 journal articles and 149 abstracts were found. Of these, 70 were considered relevant and included in this analysis. Most of the publications were uncontrolled, observational studies. Data from six randomised, controlled trials were identified. In general, the evidence revealed no clinically important efficacy or safety signals associated with switching.
conclusionsWhile available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.