Nested case‐control study utilizing MID‐NET® on thrombocytopenia associated with pegfilgrastim in patients treated with antineoplastic agents

K Kajiyama, C Ishiguro, T Ando… - Clinical …, 2021 - Wiley Online Library
Although several spontaneous case reports on the occurrence of thrombocytopenia in
patients treated with human granulocyte colony‐stimulating factor (G‐CSF) preparations …

Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-Neulasta® in the prophylaxis of chemotherapy-induced neutropenia

CF Waller, C Blakeley, E Pennella… - Annals of …, 2016 - annalsofoncology.org
Background MYL-1401H is a proposed pegfilgrastim biosimilar to the reference product EU-
Neulasta®, based on physicochemical characterization, in vitro bioassays, toxicokinetics …

Achieving white blood cell equity: are the safety profiles of biosimilar and reference pegfilgrastims comparable?

A Loaiza-Bonilla, RD Page - Future Oncology, 2024 - Future Medicine
Biosimilars can provide choices for patients and may provide cost savings; however, their
uptake has been slow in the USA, in part due to limited knowledge. To provide additional …

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double …

C Wynne, C Schwabe, E Vincent… - Pharmacology …, 2020 - Wiley Online Library
MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim
(Neulasta®). This study was designed primarily to compare the immunogenicity of …

Efficacy and safety of empegfilgrastim, a novel pegylated G-CSF: Results of complete analysis after 4 cycles of myelosuppressive chemotherapy in phase III double …

O Filon, M Nechaeva, O Burdaeva, VI Vladimirov… - 2015 - ascopubs.org
e20735 Background: Empegfilgrastim is an innovator drug product of pegylated G-CSF
indicated for prophylaxis of neutropenia in patients receiving myelosuppressive …

Comparison of Efficacy and Safety of Lupin's Pegfilgrastim with Neulastim® as an Adjunct to Chemotherapy in Patients with NonMyeloid Malignancies: A Randomised …

M JAIN, S DESAI, R NAGARKAR… - Journal of Clinical & …, 2022 - search.ebscohost.com
Introduction: Pegfilgrastim is indicated in patients receiving myelosuppressive anticancer
drugs to reduce the Duration of Severe Neutropenia (DSN) and incidence of Febrile …

[HTML][HTML] A demonstration of analytical similarity comparing a proposed biosimilar pegfilgrastim and reference pegfilgrastim

S Brokx, L Scrocchi, N Shah, J Dowd - Biologicals, 2017 - Elsevier
Background Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is
used primarily to reduce incidence and duration of severe neutropenia and its associated …

Pegfilgrastim and filgrastim patterns of use in community oncology practices: results of the ACCEPT study

LA Meza, V Charu, L Campos, D Davis… - Journal of Clinical …, 2005 - ascopubs.org
6113 Background: In pivotal trials, appropriate use of pegfilgrastim and filgrastim prevented
neutropenic complications when initiated in cycle (C) 1, 24h after chemotherapy (CT). In …

Administration of pegfilgrastim on the same day or next day of chemotherapy

PS Hoffmann - Journal of Clinical Oncology, 2005 - ascopubs.org
8137 Background: Though pegfilgrastim has reduced the number of injections compared
with filgrastim, eliminating an office visit to receive pegfilgrastim on the day after …

[HTML][HTML] Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

K Blackwell, P Gascon, CM Jones, A Nixon… - Annals of …, 2017 - Elsevier
Background Following the functional and physicochemical characterization of a proposed
biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar …