Pegfilgrastim is a colony stimulating factor (CSF) that acts on hematopoietic cells by binding to specific cell surface receptors thereby, stimulating proliferation, differentiation, commitment, and end cell functional activation.
History/Background and/or General Information
Pegfilgrastim is approved by the Food and Drug Administration to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Prophylactic use of pegfilgrastim in patients undergoing chemotherapy reduces the risk of febrile neutropenia and infections. Prophylactic therapy can be considered for patients receiving myelosuppressive chemotherapy if the risk of febrile neutropenia is 20% or greater.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are leukocyte growth factors indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf are biosimilar* to pegfilgrastim.
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastim-bmez and pegfilgrastim-apgf has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information).
