ArticlemAbs
Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 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
41 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Pooled it
- Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects.British journal of clinical pharmacology · 2017Trial
- Cancer treatment with biosimilar drugs: A review.Cancer innovation · 2024Review
- Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases.Intestinal research · 2020Review
- Are Patients at Risk for Recurrent Disease Activity After Switching From RemicadeFrontiers in medicine · 2020Article
- Observational
- Precipitation of complex antibody solutions: influence of contaminant composition and cell culture medium on the precipitation behavior.Bioprocess and biosystems engineering · 2019Article
- Article
- Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system.Drug design, development and therapy · 2019Article
- Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab.Ecancermedicalscience · 2019Review
- 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
- Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product.Biologics : targets & therapy · 2018Article
- Article
- Article
- Comparative Glycopeptide Analysis for Protein Glycosylation by Liquid Chromatography and Tandem Mass Spectrometry: Variation in Glycosylation Patterns of Site-Directed Mutagenized Glycoprotein.International journal of analytical chemistry · 2018Article
- Verification between Original and Biosimilar Therapeutic Antibody Infliximab Using nSMOL Coupled LC-MS Bioanalysis in Human Serum.Current pharmaceutical biotechnology · 2018Article
- Improving Access to Cancer Treatments: The Role of Biosimilars.Journal of global oncology · 2017Article
- Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons.Rheumatology (Oxford, England) · 2017Review
- Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.
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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.