SynthesisDrugs2018
Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes.
Synthesis in Drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 11 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
96 citing papers in PubMed, 11 syntheses or guidelines pooled it.
- Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis.Scientific reports · 2023Pooled it
- Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.PloS one · 2023Pooled it
- Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled 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
- Pharmacists' Perspectives of Biosimilars: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review.Advances in therapy · 2022Pooled it
- The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review.Clinical pharmacology and therapeutics · 2020Pooled it
- Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease.Digestive diseases and sciences · 2020Pooled it
- Pooled it
- Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review.Advances in therapy · 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
- Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Trial
- Trial
- AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.The British journal of dermatology · 2020Trial
- Biosimilar anti-vascular endothelial growth factor agents: Clinical outcomes, safety, and cost-effectiveness in India.Indian journal of ophthalmology · 2026Review
- Characteristics and safety outcomes of rheumatoid arthritis patients treated with AMGEVITAArthritis research & therapy · 2026Article
- Relapse of retinal vasculitis after a non-medical biosimilar switch: a case report.Journal of ophthalmic inflammation and infection · 2026Article
- Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye.Drugs & aging · 2026Review
- Migraine, monoclonal antibodies, and monitoring: a review of pharmacovigilance in the era of biologics.Frontiers in pharmacology · 2026Review
- The FDA's adoption of Bayesian methodology: transforming clinical trial justification from biosimilars to broader drug development.Frontiers in medicine · 2026Review
36 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTo evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars).
methodsA systematic search was conducted using the Medline
resultsPrimary data were available from 90 studies that enrolled 14,225 unique individuals. They included protein medicines used in supportive care as well as those used as therapeutic agents. The medicines contained seven different molecular entities that were used to treat 14 diseases. The great majority of the publications did not report differences in immunogenicity, safety, or efficacy. The nature and intensity of safety signals reported after switching from reference medicines to biosimilars were the same as those already known from continued use of the reference medicines alone. Three large multiple switch studies with different biosimilars did not show differences in efficacy or safety after multiple switches between reference medicine and biosimilar. Two publications reported a loss of efficacy or increased dropout rates.
conclusionsWhile use of each biologic must be assessed individually, these results provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine.
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Identifiers
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.