Trial reportAnnals of hematology2010
Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial.
Trial report in Annals of hematology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 39 citations in OpenAlex.
- Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects.British journal of clinical pharmacology · 2018Trial
- A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.Journal of cancer research and clinical oncology · 2018Trial
- Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers.Drug design, development and therapy · 2018Trial
- Trial
- Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study.Drugs - real world outcomes · 2022Article
- Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Transplantation Seems Less Efficacious in Poor Mobilizers with the Use of a Biosimilar of Filgrastim and Plerixafor: A Retrospective Comparative Analysis.Oncology and therapy · 2020Article
- Efficacy and Safety of Nivestim Versus Neupogen for Mobilization of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation.Scientific reports · 2019Article
- Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation.Bone marrow transplantation · 2019Article
- Trial Design and Statistical Considerations on the Assessment of Pharmacodynamic Similarity.The AAPS journal · 2019Article
- Algorithms utilizing peripheral blood hematopoietic progenitor cell counts in lieu of some CD34ISBT science series · 2016Article
- Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.Advances in therapy · 2016Article
- Clinical experience with Zarzio® in Europe: what have we learned?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013Review
- Update on the safety and bioequivalence of biosimilars - focus on enoxaparin.Drug, healthcare and patient safety · 2013Article
- Biosimilar rhG-CSFs: how similar are they?Targeted oncology · 2012Article
- Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials.Ungyong t'onggye yon'gu = The Korean journal of applied statistics · 2011Article
- Histological study on the protective effect of endogenous stem-cell mobilization in Adriamycin-induced chronic nephropathy in rats.Journal of microscopy and ultrastructureArticle
- Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products.mAbsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Further to the patent expiry of Neupogen (Amgen filgrastim), Hospira has developed a biosimilar filgrastim (Nivestim) that may offer a clinically effective alternative for multiple hematologic and oncologic indications. Here results are reported from a phase I trial, primarily designed to compare the pharmacodynamic profiles of Hospira filgrastim and Amgen filgrastim. A phase I, single-center, double-blind, randomized trial was undertaken to demonstrate equivalence of the pharmacodynamic characteristics of Hospira filgrastim and Amgen filgrastim. Fifty healthy volunteers were randomized to receive 5 or 10 microg/kg dosing, before further randomization to treatment sequence. All volunteers received five daily subcutaneous doses of Hospira filgrastim or Neupogen, with subsequent crossover to the alternative treatment. Bioequivalence was evaluated by analysis of variance; if the estimated 90% confidence intervals (CIs) for the ratio of 'test' to 'reference' treatment means were within the conventional equivalence limits of 0.80-1.25, then bioequivalence was concluded. Forty-eight volunteers completed the study. Geometric mean absolute neutrophil count area under the curve from time 0 to the last time point at day 5 (primary endpoint) was comparable in volunteers given Hospira filgrastim or Amgen filgrastim at 5 microg/kg (ratio of means, 0.98; 90% CI, 0.92-1.05) or 10 microg/kg (ratio, 0.97; 90% CI, 0.93-1.01); 90% CIs were within the predefined range necessary to demonstrate bioequivalence. Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim. Hospira filgrastim is bioequivalent with Amgen filgrastim with regard to its pharmacodynamic characteristics.
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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.