ReviewBreast cancer research and treatment2014
Expert perspectives on biosimilar monoclonal antibodies in breast cancer.
Review in Breast cancer research and treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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, 51 citations in OpenAlex.
- PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.British journal of cancer · 2019Trial
- Totality of Evidence Supporting the Use of ABP 980, a Trastuzumab Biosimilar: Practical Considerations.Oncology and therapy · 2021Article
- Immune-related gene data-based molecular subtyping related to the prognosis of breast cancer patients.Breast cancer (Tokyo, Japan) · 2021Article
- Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to HerceptinBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Article
- Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Review
- Towards personalized treatment for early stage HER2-positive breast cancer.Nature reviews. Clinical oncology · 2020Review
- Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab.Targeted oncology · 2019Review
- Article
- The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars.British journal of cancer · 2019Review
- Hydrodynamic and Electrophoretic Properties of Trastuzumab/HER2 Extracellular Domain Complexes as Revealed by Experimental Techniques and Computational Simulations.International journal of molecular sciences · 2019Article
- The evolution of biosimilars in oncology, with a focus on trastuzumab.Current oncology (Toronto, Ont.) · 2018Review
- Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans.British journal of clinical pharmacology · 2018Article
- Effectiveness of biosimilar filgrastim vs. original granulocyte colony-stimulating factors in febrile neutropenia prevention in breast cancer patients.European journal of clinical pharmacology · 2018Observational
- Article
- Clinical equivalence with G-CSF biosimilars: methodologic approach in a (neo)adjuvant setting in non-metastatic breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Review
- Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Review
- A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients.SpringerPlus · 2015Article
- Biosimilars in rheumatology: what the clinician should know.RMD open · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
While biosimilars of low molecular-weight biologics such as G-CSF have been available in Europe since 2006, biosimilars of monoclonal antibodies (mAbs) have only become available in the last year. Unlike G-CSF, mAbs are large and complex and often play a direct role in the survival of patients with life-threatening illnesses such as breast cancer. Several biosimilars are currently under development for the treatment of breast cancer, and the use of biosimilars in a setting that directly impacts patient survival raises a number of questions. In this review, we discuss the biosimilar mAbs currently in development for the treatment of breast cancer. We provide an overview of the European Medicine Agency guidelines and historic data on the development of biosimilars in order to discuss the development of biosimilar mAbs for breast cancer. Biosimilars offer a highly attractive path toward reducing the cost of medical care and should be pursued with great interest. However, for agents used to treat life-threatening diseases such as cancer, a cautious approach must be taken to ensure that there is no negative impact on patient care. Clinical trials for biosimilar mAbs must be carried out in an appropriately sensitive patient population using endpoints that can accurately demonstrate both the similarity of the biosimilar and its efficacy in the indication. Due to the abbreviated approval pathway, rigorous pharmacovigilance must be in place once a biosimilar mAb is approved in order to ensure its long-term safety and efficacy.
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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.