A retrospective review of the real-world experience of the pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®)
G Wong, L Zhang, H Majeed, Y Razvi… - Journal of Oncology …, 2022 - journals.sagepub.com
Introduction Cancer patients receiving myelosuppressive chemotherapy are vulnerable to
febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of …
febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of …
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim
CF Waller, RG Tiessen, TE Lawrence, A Shaw… - Journal of Cancer …, 2018 - Springer
Purpose Pegfilgrastim is a long-acting granulocyte colony-stimulating factor indicated for
prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy by …
prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy by …
Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study
BACKGROUND: Real-world evidence on the comparative effectiveness of pegfilgrastim
biosimilars compared with the originator product is limited. OBJECTIVE: To compare the risk …
biosimilars compared with the originator product is limited. OBJECTIVE: To compare the risk …
Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US …
K Desai, P Misra, S Kher, N Shah - Experimental Hematology & Oncology, 2018 - Springer
Background Chemotherapy-induced neutropenia is a common result of myelosuppressive
chemotherapy treatment. Infections such as febrile neutropenia (FN) are sensitive to the …
chemotherapy treatment. Infections such as febrile neutropenia (FN) are sensitive to the …
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 …
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 …
[HTML][HTML] Pegfilgrastim Biosimilars: Where Are We Now?
C Selby, B Peyton-Thomas, P Eslami - Journal of the Advanced …, 2021 - ncbi.nlm.nih.gov
Abstract In 1991, the US Food & Drug Administration (FDA) approved rmetHuGCSF for
human use. This recombinant methionyl human granulocyte colony-stimulating factor, or …
human use. This recombinant methionyl human granulocyte colony-stimulating factor, or …
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 …
Pegfilgrastim biosimilars in US supportive oncology: a narrative review of administration options and economic considerations to maximize patient benefit
SZ Humphreys, RB Geller, P Walden - Oncology and Therapy, 2022 - Springer
Granulocyte colony-stimulating factor (G-CSF) biologics, such as pegfilgrastim, are a
standard of care in supportive cancer treatment that are administered once per …
standard of care in supportive cancer treatment that are administered once per …
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 …
uptake has been slow in the USA, in part due to limited knowledge. To provide additional …