SynthesisClinical pharmacology and therapeutics2020
The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review.
Synthesis in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 9 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
72 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.International journal of clinical pharmacy · 2025Pooled it
- Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review.Pharmaceutical medicine · 2024Pooled 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
- 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
- Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Pooled it
- Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Pooled it
- Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability.Advances in therapy · 2025Trial
- Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile.Frontiers in immunology · 2024Trial
- Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial.BMJ open ophthalmology · 2023Trial
- Assessing the Interchangeability of AVT02 and HumiraBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Trial
- Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Trial
- Biosimilar use in medical oncology in Ireland: a missed opportunity to mitigate financial toxicity?International journal of clinical pharmacy · 2026Article
- Ten-Year Public Expenditure Savings Associated with TNF Inhibitor Biosimilars under Australia's Pharmaceutical Benefits Scheme.Clinical pharmacology and therapeutics · 2026Article
- Regulatory and safety challenges of biosimilars: insights from developed and emerging economies.European journal of clinical pharmacology · 2026Review
- Position statement of the Biotechnology Committee of the Brazilian Society of Rheumatology on the interchangeability of originator and biosimilar biologics in immune-mediated rheumatic diseases.Advances in rheumatology (London, England) · 2026Review
- The FDA's adoption of Bayesian methodology: transforming clinical trial justification from biosimilars to broader drug development.Frontiers in medicine · 2026Review
- Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks.Frontiers in drug delivery · 2026Review
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa affects efficacy, safety, or immunogenicity outcomes. A total of 178 studies, in which switch outcomes from a RP to a biosimilar were reported, was identified. Data were derived from both randomized controlled trials and real-world evidence. Despite the limitations stemming from a lack of a robust design for most of the studies, the available switching data do not indicate that switching from a RP to a biosimilar is associated with any major efficacy, safety, or immunogenicity issues. Some open-label and observational studies reported increased discontinuation rates after switching, which were mainly attributed to nocebo effects. Involvement of the prescriber in any decision to switch should remain and attention should be paid to the mitigation of a potential nocebo effect.
Indexed as
Identifiers
What Socratic 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 Socratic graph.