SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2016
Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.
Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 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
18 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024Pooled it
- Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab.Journal of experimental pharmacology · 2021Article
- Asthma biologics: Comparing trial designs, patient cohorts and study results.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2020Review
- Structural and In Vitro Functional Comparability Analysis of Altebrel™, a Proposed Etanercept Biosimilar: Focus on Primary Sequence and Glycosylation.Pharmaceuticals (Basel, Switzerland) · 2019Article
- Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq.Open access rheumatology : research and reviews · 2019Review
- The Clinical Implications of Nocebo Effects for Biosimilar Therapy.Frontiers in pharmacology · 2019Review
- Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.The oncologist · 2018Review
- Next generation antibody drugs: pursuit of the 'high-hanging fruit'.Nature reviews. Drug discovery · 2018Review
- The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2018Article
- Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis.PharmacoEconomics · 2017Review
- Improving Access to Cancer Treatments: The Role of Biosimilars.Journal of global oncology · 2017Article
- Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points.The AAPS journal · 2017Article
- Intracoronary Imaging, Cholesterol Efflux, and Transcriptomics after Intensive Statin Treatment in Diabetes.Scientific reports · 2017Article
- Maintenance Therapies in Indolent Lymphomas: should Recent Data Change the Standard of Care?Current treatment options in oncology · 2017Review
- Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.
objectivesThe objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.
methodsMEDLINE, Embase, and ISI Web of Science were searched to September 2015. Conference proceedings (n = 17) were searched 2012 to July 2015. Included studies were categorized by originator, study type, and indication. To assess data strength and validity, risk of bias assessments were undertaken.
resultsAcross therapeutic areas, 43 named (marketed or proposed) biosimilars were identified for adalimumab, abciximab, bevacizumab, etanercept, infliximab, omalizumab, ranibizumab, rituximab, and trastuzumab originators. Infliximab CT-P13, SB2, and etanercept SB4 biosimilars have the greatest amount of published evidence of similarity with their originators, based on results of clinical studies involving larger numbers of patients or healthy subjects (N = 1405, 743, and 734, respectively). Published data were also retrieved for marketed intended copies of etanercept and rituximab.
conclusionsThis unbiased synthesis of the literature exposed significant differences in the extent of published evidence between molecules at preclinical, clinical, and post-marketing stages of development, providing clinicians and payers with a consolidated view of the available data and remaining gaps.
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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.