SynthesisPloS one2023
Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.
Synthesis in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 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
29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Ustekinumab Biosimilars versus Reference Ustekinumab for Moderate-to-Severe Plaque Psoriasis: A Pre-switch Systematic Review and Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Pooled it
- AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis.Gastroenterology · 2024Guideline
- Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review.Pharmaceutical medicine · 2024Pooled it
- Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Pooled it
- Four decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)- Part I: Product Quality.The AAPS journal · 2026Review
- Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Major US Formulary Change Triggers, but Does Not Sustain, Increases in Biosimilar Adalimumab Prescribing.Arthritis care & research · 2026Article
- Therapeutic Applications of Immunobiologics in Autoimmune and Inflammatory Diseases.Pharmaceutics · 2026Review
- The Future of Biologics: Lessons from Hatch-Waxman.Therapeutic innovation & regulatory science · 2026Article
- Measuring the Impact of the Substitution of Innovator Biologics With Biosimilars on Uptake and Costs Among Ontario Public Drug Benefit Recipients.Clinical pharmacology and therapeutics · 2026Article
- Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects.International journal of retina and vitreous · 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
- Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability.Therapeutic innovation & regulatory science · 2025Review
- Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Drivers of infliximab biosimilar uptake: A comparative analysis of new biosimilar initiations versus switching in a national rheumatology registry.Health services research · 2025Article
- Breaking Barriers: Essential Reforms for a Competitive and Affordable Biosimilars Market.Current rheumatology reports · 2025Review
- Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies.International journal of clinical pharmacy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilars are increasingly available for the treatment of many serious disorders, however some concerns persist about switching a patient to a biosimilar whose condition is stable while on the reference biologic. Randomized controlled studies and extension studies with a switch treatment period (STP) to or from a biosimilar and its reference biologic were identified from publicly available information maintained by the U.S. Food and Drug Administration (FDA). These findings were augmented with data from peer reviewed publications containing information not captured in FDA reviews. Forty-four STPs were identified from 31 unique studies for 21 different biosimilars. Data were extracted and synthesized following PRISMA guidelines. Meta-analysis was conducted to estimate the overall risk difference across studies. A total of 5,252 patients who were switched to or from a biosimilar and its reference biologic were identified. Safety data including deaths, serious adverse events, and treatment discontinuation showed an overall risk difference (95% CI) of -0.00 (-0.00, 0.00), 0.00 (-0.01, 0.01), -0.00 (-0.01, 0.00) across STPs, respectively. Immunogenicity data showed similar incidence of anti-drug antibodies and neutralizing antibodies in patients within a STP who were switched to or from a biosimilar to its reference biologic and patients who were not switched. Immune related adverse events such as anaphylaxis, hypersensitivity reactions, and injections site reactions were similar in switched and non-switched patients. This first systematic review using statistical methods to address the risk of switching patients between reference biologics and biosimilars finds no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar.
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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.