ArticleEJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.]2013
Clinical considerations for biosimilar antibodies.
Article in EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.], 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 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
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Alimentary pharmacology & therapeutics · 2019Pooled it
- Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Originator versus biosimilar adalimumab in hidradenitis suppurativa: A multicenter real-world analysis of clinical response, maintenance of response, and switching.JAAD international · 2026Article
- The impact of EU public procurement regulations on tenders in Spain: a study with adalimumab.Frontiers in pharmacology · 2024Article
- The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn.Journal of diabetes science and technology · 2023Review
- Biosimilars in Oncology: Latest Trends and Regulatory Status.Pharmaceutics · 2022Review
- Brain Distribution of Drugs: Pharmacokinetic Considerations.Handbook of experimental pharmacology · 2022Article
- Article
- Current and future roles of biosimilars in oncology practice.Oncology letters · 2020Review
- Article
- The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond.Journal of food and drug analysis · 2019Review
- Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Article
- Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans.British journal of clinical pharmacology · 2018Article
- Infliximab Biosimilars: A Promising but Unusual Treatment for Mycobacterial Immune Reconstitution Inflammatory Syndrome in Human Immunodeficiency Virus-Infected Patients.Open forum infectious diseases · 2017Article
- Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study.Frontiers in pharmacology · 2017Article
- Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.Drugs · 2016Review
- Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.Frontiers in pharmacology · 2016Review
- Biosimilar insulins: a European perspective.Diabetes, obesity & metabolism · 2015Review
- Etanercept biosimilars.Rheumatology international · 2015Review
- Pharmacovigilance of biosimilars - Why is it different from generics and innovator biologics?Journal of postgraduate medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar monoclonal antibodies (mAbs). Biosimilar mAbs represent a distinct class given their large molecular size, complex protein structure, and post-translational modifications. While guidelines have been established for the development, approval, and use of biosimilars, further scrutiny and discussion is necessary to fully understand their potential impact on clinical outcomes. This review takes a critical look at the structural complexity of biosimilar mABs, the feasibility of indication extrapolation, the impact of product variability on immunogenicity, the importance of comprehensive pharmacovigilance, and the potential for ongoing pharmacoeconomic impact.
Indexed as
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.