Trial reportClinical pharmacology in drug development2016
Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim.
Trial report in Clinical pharmacology in drug development, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.Clinical pharmacology in drug development · 2021Pooled it
- Single-Dose Pharmacokinetics, Pharmacodynamics and Immunogenicity, and Multiple-Dose Immunogenicity of INTP5 (Pegfilgrastim Biosimilar) Versus Reference Pegfilgrastim in Healthy Subjects.Clinical drug investigation · 2021Trial
- A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.British journal of clinical pharmacology · 2020Trial
- Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of PelmegPharmacology research & perspectives · 2019Trial
- Pharmacodynamics, safety, and immunogenicity of PelmegPharmacology research & perspectives · 2019Trial
- Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects.British journal of clinical pharmacology · 2018Trial
- Analytical assessment of safety and efficacy of filgrastim and pegfilgrastim formulations for treatment of chemotherapy-induced neutropenia.3 Biotech · 2025Article
- A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®).Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2022Article
- PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (NeulastaAdvances in therapy · 2020Article
- Is It Better to Mobilize Hematopoietic Stem Cells With Pegfilgrastim in Healthy Donors During Allogeneic Hematopoietic Stem Cell Transplantation?Frontiers in oncology · 2020Article
- Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy.Experimental hematology & oncology · 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
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A phase 1 pharmacokinetic (PK) and pharmacodynamic (PD) study was conducted to demonstrate similarity of a proposed pegfilgrastim biosimilar to its reference product. In a single-dose, randomized, assessor-blinded, 2-way crossover, active-controlled PK/PD study, 66 healthy adults received the proposed pegfilgrastim biosimilar and US-licensed pegfilgrastim reference product. Primary end points were pegfilgrastim AUCt and Cmax (PK), and absolute neutrophil count AUECt and Emax (PD). Safety and immunogenicity were also measured. Fifty-six subjects completed both arms of the study. Mean pegfilgrastim concentration-time profile for both products was similar, with the 90% confidence intervals (CI) of the relative mean ratio for the primary end points falling within the predefined acceptance criteria of 80%-125% (91.7%-116.1% and 86.7%-110.2% for AUCt and Cmax , respectively). PD similarity was also demonstrated by the 95%CI of the relative mean ratio of the primary end point parameters within the predefined acceptance margins of 80%-125% (96.0%-101.6% and 92.6%-100.1% for AUECt and Emax , respectively). No statistically meaningful PK/PD differences were observed. No clinically meaningful safety or immunological differences were observed with the proposed pegfilgrastim biosimilar that were not previously identified with the reference product. The proposed pegfilgrastim biosimilar product is highly similar to the reference product with regard to PK/PD.
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