Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 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.
A Randomized Open-label, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous Administration To Healthy Volunteers
A Randomized Open-Label, Single-Dose, Crossover Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Filgrastim Hospira Compared To U.S.-Approved Neupogen® (Amgen) Following Subcutaneous Administration To Healthy Volunteers
A Phase I, Randomized Open-label, 2-period, Parallel Arm Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of "Filgrastim Hospira" (US) Or US-approved Neupogen(Registered) Reference Product In Healthy Volunteers
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Clinical decision support for chemotherapy-induced neutropenia using a hybrid pharmacodynamic/machine learning model.CPT: pharmacometrics & systems pharmacology · 2023Article
- 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
- Supportive therapies in the prevention of chemotherapy-induced febrile neutropenia and appropriate use of granulocyte colony-stimulating factors: a Delphi consensus statement.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities.Pharmaceuticals (Basel, Switzerland) · 2021Article
- 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
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThree comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen
methodsTwo separate open-label, crossover-design PK/PD studies were conducted: a single-dose study (n = 24) and a multiple-dose study (n = 60). In each study, HVs were randomized to Nivestym followed by US-Neupogen, or vice versa. Study drug (5 μg/kg) was administered subcutaneously as a single injection or as five consecutive daily injections. Primary PK and PD endpoints were area under the filgrastim serum concentration-time curve, maximum observed concentration, area under the effect curve (AUEC) for absolute neutrophil count (ANC), maximum observed ANC, AUEC for cluster of differentiation (CD)-34
resultsOverall demographics were as follows: female (n = 162/340); White (n = 274/340), Black (n = 58/340), and other (n = 8/340); age (18-65 years); and weight (50.8-96.5 kg). All primary PK and PD endpoints met the pre-specified criteria for PK and PD equivalence. The primary endpoint in the comparative immunogenicity study met pre-specified criteria for non-inferiority.
conclusionsNivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.
trial registrationClinicalTrials.gov C1121002 (NCT02766647); C1121003 (NCT02766634); C1121012 (NCT02923791).
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.