Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

Abstract Background Chemotherapy-induced neutropenia is a common result of myelosuppressive chemotherapy treatment. Infections such as febrile neutropenia (FN) are sensitive to the duration of neutropenia as well as the depth of absolute neutrophil count (ANC) at nadir. Filgrastim, a granulocyte col...

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Bibliographic Details
Main Authors: Kalpna Desai, Priya Misra, Sanyukta Kher, Nirmesh Shah
Format: Article
Language:English
Published: BMC 2018-09-01
Series:Experimental Hematology & Oncology
Subjects:
Biosimilar
Pegfilgrastim
Chemotherapy-induced neutropenia
Severe neutropenia
Febrile neutropenia
Absolute neutrophil count
Online Access:http://link.springer.com/article/10.1186/s40164-018-0114-9

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http://link.springer.com/article/10.1186/s40164-018-0114-9

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