H Sourgens1, F Lefrère. 1. University of Münster, Münster, Germany. info@sourgens.de
Abstract
BACKGROUND: Filgrastim (Neu-pogen®, Amgen) and lenograstim (Granocyte®, Chugai Pharma) are chemically different granulocyte colony-stimulating factors (G-CSFs). Based on receptor-binding studies and in vitro potency assessment, a clinical superiority of lenograstim versus filgrastim has been postulated together with potential cost savings favouring lenograstim over filgrastim. OBJECTIVES: To compare the clinical efficacy of filgrastim and lenograstim based on current Summaries of Product Characteristics (SPCs) for both products taking into account published clinical trials in patients and healthy volunteers. SEARCH STRATEGY AND SELECTION CRITERIA: PubMed and citation lists of published articles were used to identify clinical trials with direct comparisons of filgrastim and lenograstim. All available clinical information directly comparing filgrastim and lenograstim has been accepted for evaluation. DATA COLLECTION: A total of 16 studies compared filgrastim with lenograstim. Four studies had a randomized, parallel-group design, 4 had a cross-over design and 8 studies were uncontrolled. RESULTS: Available data do not suggest a clinically remarkable difference between filgrastim and lenograstim in chemotherapy-induced neutropenia and the mobilisation of peripheral blood progenitor cells (PBPC) in patients and healthy donors. CONCLUSIONS: Both G-CSFs are recommended for clinical use according to instructions in the respective SPCs; there is no reason to prefer lenograstim over filgrastim in any of the approved indications for both. Costs calculations need to consider the advent of biosimilar filgrastim in Europe.
BACKGROUND: Filgrastim (Neu-pogen®, Amgen) and lenograstim (Granocyte®, Chugai Pharma) are chemically different granulocyte colony-stimulating factors (G-CSFs). Based on receptor-binding studies and in vitro potency assessment, a clinical superiority of lenograstim versus filgrastim has been postulated together with potential cost savings favouring lenograstim over filgrastim. OBJECTIVES: To compare the clinical efficacy of filgrastim and lenograstim based on current Summaries of Product Characteristics (SPCs) for both products taking into account published clinical trials in patients and healthy volunteers. SEARCH STRATEGY AND SELECTION CRITERIA: PubMed and citation lists of published articles were used to identify clinical trials with direct comparisons of filgrastim and lenograstim. All available clinical information directly comparing filgrastim and lenograstim has been accepted for evaluation. DATA COLLECTION: A total of 16 studies compared filgrastim with lenograstim. Four studies had a randomized, parallel-group design, 4 had a cross-over design and 8 studies were uncontrolled. RESULTS: Available data do not suggest a clinically remarkable difference between filgrastim and lenograstim in chemotherapy-induced neutropenia and the mobilisation of peripheral blood progenitor cells (PBPC) in patients and healthy donors. CONCLUSIONS: Both G-CSFs are recommended for clinical use according to instructions in the respective SPCs; there is no reason to prefer lenograstim over filgrastim in any of the approved indications for both. Costs calculations need to consider the advent of biosimilar filgrastim in Europe.
Authors: Roberto Guariglia; Maria Carmen Martorelli; Rosa Lerose; Donatella Telesca; Maria Rita Milella; Pellegrino Musto Journal: Biologics Date: 2016-01-22