[HTML][HTML] Comparison of immunogenicity between the proposed pegfilgrastim biosimilar MYL-1401H and reference pegfilgrastim
C Waller, GM Ranganna, E Pennella, LA Mattano… - Blood, 2017 - Elsevier
Introduction: Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is
indicated for reduction of incidence of febrile neutropenia in patients with non-myeloid …
indicated for reduction of incidence of febrile neutropenia in patients with non-myeloid …
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 …
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 …
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 …
(Neulasta®). This study was designed primarily to compare the immunogenicity of …
[HTML][HTML] PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta®) …
S Moosavi, T Borema, R Ewesuedo, S Harris, J Levy… - Advances in …, 2020 - Springer
Introduction PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta®). This study
evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity …
evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity …
[HTML][HTML] Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim …
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 …
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 …
[HTML][HTML] Biosimilar pegfilgrastim-cbqv demonstrated similar immunogenicity to pegfilgrastim in healthy subjects across three randomized clinical studies
F Civoli, B Finck, H Tang, J Hodge, H O'Kelly… - Advances in Therapy, 2022 - Springer
Introduction Biologic therapeutics can trigger immune responses in patients. As part of the
totality of evidence that is required for regulatory approval of biosimilars, immunogenicity …
totality of evidence that is required for regulatory approval of biosimilars, immunogenicity …
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 …
[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 …
biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar …