ArticleDrug safety2013
Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis 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
28 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Pooled it
- From Product-Quality Complaints to Patient-Safety Triage: A Structured Narrative Review and Proposed PRCS-TRACE Framework.Healthcare (Basel, Switzerland) · 2026Review
- Migraine, monoclonal antibodies, and monitoring: a review of pharmacovigilance in the era of biologics.Frontiers in pharmacology · 2026Review
- Adverse drug events associated with sodium zirconium cyclosilicate: A real-world pharmacovigilance study based on the FAERS database.PloS one · 2025Article
- The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- An extensive survey on the use of supervised machine learning techniques in the past two decades for prediction of drug side effects.Artificial intelligence review · 2023Article
- Pharmacoepidemiological Research on N-Nitrosodimethylamine-Contaminated Ranitidine Use and Long-Term Cancer Risk: A Population-Based Longitudinal Cohort Study.International journal of environmental research and public health · 2022Observational
- Pharmacovigilance Bibliometrics: Visualizing Thematic Development in the Category of Pharmacology and Pharmacy in Web of Science.Frontiers in pharmacology · 2021Article
- Article
- Evolution of the EU Biosimilar Framework: Past and Future.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Review
- Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.Pharmaceutical medicine · 2019Article
- Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.Clinical pharmacology and therapeutics · 2019Article
- Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.Drug safety · 2018Review
- Challenges and Opportunities for the Traceability of (Biological) Medicinal Products.Drug safety · 2018Article
- Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Article
- Biosimilars in rheumatology: understanding the rigor of their development.Rheumatology (Oxford, England) · 2017Review
- Article
- Pharmacoeconomics of Biosimilars: What Is There to Gain from Them?Current rheumatology reports · 2016Review
- The changing landscape of biosimilars in rheumatology.Annals of the rheumatic diseases · 2016Review
- Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology.Rheumatology international · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected.
objectiveThe aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs. DESIGN AND
settingA cross-sectional study was conducted over the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU.
main outcome measuresThe availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs. For biopharmaceuticals for which a biosimilar has been approved for marketing in the EU, the identifiability of the product (i.e. the possibility of distinguishing the biosimilar from the reference biopharmaceutical) was determined.
resultsA total of 2,028,600 unique ADR reports were identified in the FAERS, reporting a total of 591,380 biopharmaceuticals (of which 487,065 were suspected). In EV there were 2,108,742 unique ADR reports, reporting a total of 439,971 biopharmaceuticals (356,293 suspected). Overall, for 24.0 % of the suspected biopharmaceuticals in the FAERS and 7.4 % of the suspected small molecule drugs (p < 0.001) batch numbers were available. A similar pattern was seen in EV: for 21.1 % of the suspected biopharmaceuticals batch numbers were available, compared with only 3.6 % of the small molecule drugs (p < 0.001). In both SRSs, consumers were most likely to report a batch number for suspected biologicals (36.3 % in the FAERS and 40.7 % in EV). A total of 13,790 biopharmaceuticals (9,759 suspected) for which a biosimilar has been approved in the EU were identified in EV. For 90.4 % of these biopharmaceuticals and 96.2 % of the suspected biopharmaceuticals the product was clearly identifiable.
conclusionThis study underlines the need for improving traceability of biopharmaceuticals, in particular with respect to individual batches, allowing better identification and monitoring of postmarketing safety issues related to biopharmaceuticals.
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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 OpenQuestion graph.