ReviewSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2013
Clinical experience with Zarzio® in Europe: what have we learned?
Review in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 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
44 citing papers in PubMed, 1 synthesis or guideline pooled it, 101 citations in OpenAlex.
- Pooled it
- Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.Future oncology (London, England) · 2016Trial
- Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.Annals of oncology : official journal of the European Society for Medical Oncology · 2015Trial
- Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2015Trial
- Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Efficacy and safety of biosimilar Peg-filgrastim after autologous stem cell transplant in myeloma and lymphoma patients: a comparative study with biosimilar Filgrastim, Lenograstim, and originator Peg-filgrastim.Annals of hematology · 2024Article
- Fostering healthcare system sustainability through efficient practices: Can adopting biosimilars ease the financial burden of rheumatoid arthritis?F1000Research · 2024Review
- Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience.Annals of transplantation · 2023Article
- Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit.Oncology and therapy · 2022Review
- Oncology biosimilars: New developments and future directions.Cancer reports (Hoboken, N.J.) · 2022Review
- Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review.Advances in therapy · 2020Review
- Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- 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
- Emerging Role of Biosimilars in Oncology-Hematology in Saudi Arabia: A Practical Perspective.Global journal on quality and safety in healthcare · 2020Review
- Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Review
- Treatment patterns and outcomes in patients with non-small cell lung cancer receiving biosimilar filgrastim for prophylaxis of chemotherapy-induced/febrile neutropaenia: Results from the MONITOR-GCSF study.European journal of cancer care · 2019Article
- What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?Breast care (Basel, Switzerland) · 2019Review
- Article
- Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product.Pharmaceutical research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and pharmacodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10-20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.
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.