A large multicentre, randomized, double‐blind, cross‐over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim …
A Bellon, J Wang, A Skerjanec… - British Journal of …, 2020 - Wiley Online Library
Aims Recombinant PEGylated human granulocyte colony‐stimulating factor (pegfilgrastim)
is indicated for the reduction of chemotherapy‐induced neutropenia and prevention of …
is indicated for the reduction of chemotherapy‐induced neutropenia and prevention of …
Pegfilgrastim: using pegylation technology to improve neutropenia support in cancer patients
G Molineux - Anti-cancer drugs, 2003 - journals.lww.com
Pegylation of a protein can improve not only its formulation properties, but also both its
pharmacokinetic and pharmacodynamic performance. Pegfilgrastim was made by linking a …
pharmacokinetic and pharmacodynamic performance. Pegfilgrastim was made by linking a …
Randomized, single-blind, crossover study to assess the pharmacokinetic and pharmacodynamic bioequivalence of CHS-1701 to pegfilgrastim in healthy subjects.
JA Glaspy, PG O'Connor, H Tang, B Finck - 2017 - ascopubs.org
e21693 Background: CHS-1701 is a proposed biosimilar of pegfilgrastim, a pegylated form
of recombinant human granulocyte colony stimulating factor approved for decreasing …
of recombinant human granulocyte colony stimulating factor approved for decreasing …
Biosimilar versus originator pegfilgrastim for preventing chemotherapy-induced neutropenia: a phase III randomized, multicenter, evaluator-blinded, noninferiority …
RD Kowalyszyn, LE Fein, ME Richardet… - JCO Global …, 2022 - ascopubs.org
PURPOSE This study evaluated the efficacy, safety, and immunogenicity of biosimilar
pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 …
pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 …
A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006)
SS Agarwala, U Nagl, X Guo, A Bellon… - Current Medical …, 2022 - Taylor & Francis
Objective The totality-of-evidence approach requires that similarity between a proposed
biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical …
biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical …
Meta‐analysis of pharmacokinetic/pharmacodynamic results of 3 phase 1 studies with biosimilar Pegfilgrastim
S Gattu, J Wang, A Bellon, C Schelcher… - Clinical …, 2021 - Wiley Online Library
A meta‐analysis using data from 3 phase 1 studies evaluated the pharmacokinetics (PK)
and pharmacodynamics (PD) of Sandoz biosimilar versus US‐and EU‐reference …
and pharmacodynamics (PD) of Sandoz biosimilar versus US‐and EU‐reference …
Characterization and similarity assessment of a pegfilgrastim biosimilar MYL-1401H.
PK Sankaran, DV Palanivelu, R Nair, PSE Nair, HV Pai… - 2018 - ascopubs.org
e19028 Background: MYL-1401H is a proposed biosimilar of pegfilgrastim (Neulasta [peg-
GCSF]), a long-acting granulocyte colony-stimulating factor (GCSF) indicated for prevention …
GCSF]), a long-acting granulocyte colony-stimulating factor (GCSF) indicated for prevention …
Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor–expanding uses in cancer chemotherapy
M Morishita, RC Leonard - Expert Opinion on Biological Therapy, 2008 - Taylor & Francis
Background: Currently G-CSFs such as filgrastim (Neupogen®, Amgen, Inc.) and
pegfilgrastim (Neulasta®, Amgen, Inc.) are widely used to reduce chemotherapy-induced …
pegfilgrastim (Neulasta®, Amgen, Inc.) are widely used to reduce chemotherapy-induced …
A large multi-center, randomized, double-blind, crossover study in healthy volunteers to compare pharmacokinetics and pharmacodynamics of a proposed biosimilar …
R Nakov, S Schussler, S Schier-Mumzhiu… - Annals of …, 2018 - annalsofoncology.org
Background: Biosimilar development applies a totality of evidence approach, in which
Phase I (pharmacokinetic [PK]/pharmacodynamics [PD]) studies have a pivotal role. Phase I …
Phase I (pharmacokinetic [PK]/pharmacodynamics [PD]) studies have a pivotal role. Phase I …
A pharmacokinetics and pharmacodynamics equivalence trial of proposed pegfilgrastim biosimilar, MYL-1401H vs EU neulasta® and US neulasta®
CF Waller, R Tiessen, T Lawrence, A Shaw… - Annals of …, 2016 - annalsofoncology.org
Methods This single-center, randomized, double-blind, 3-period, 3-treatment, 3-way
crossover trial was conducted in healthy adult male and female volunteers. The primary …
crossover trial was conducted in healthy adult male and female volunteers. The primary …