NEUPOGEN (filgrastim)


Drug overview for NEUPOGEN (filgrastim):

Generic name: FILGRASTIM (fil-GRA-stim)
Drug class: Leukocyte Stimulating Factors
Therapeutic class: Hematological Agents

Filgrastim is a biosynthetic (recombinant DNA origin) hematopoietic agent (human granulocyte colony-stimulating factor (G-CSF)) that principally affects the proliferation and differentiation of neutrophils within the bone marrow and possibly other sites (e.g., spleen). Filgrastim and tbo-filgrastim are structurally and pharmacologically similar drugs that contain a related drug substance. Tbo-filgrastim was licensed by the US Food and Drug Administration (FDA) through a biologics license application (BLA), not as a biosimilar to filgrastim; at the time of tbo-filgrastim's submission for approval, FDA had not finalized a process for approving biosimilars.

Filgrastim-sndz, filgrastim-aafi, and filgrastim-ayow are biosimilar to filgrastim (Neupogen(R)). The FDA defines a biosimilar as a biological that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).

Therefore, biosimilarity of 2 drugs may be established even when there are formulation or minor structural differences or minor differences in rates of adverse effects between the drugs as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alternation or switch.

Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. None of the currently available filgrastim biosimilars have interchangeable data at this time. In this monograph, unless otherwise stated, the term ''filgrastim products'' refers to filgastrim (the reference drug); tbo-filgrastim; filgrastim-sndz, filgrastim-aafi, and filgrastim-ayow (the biosimilars), or all products.

Various filgrastim biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in the table below (See Table 1.) Biosimilarity of the filgrastim products has not been demonstrated for use in patients with acute exposure to myelosuppressive doses of radiation; only the reference product (Neupogen(R)) is currently indicated for this use. Table 1.

Filgrastim Biosimilar Product and FDA-licensed Indications. FDA-labeled Filgrastim-sndz Filgrastim-aafi Filgrastim-ayow indication (Zarxio(R)) (Nivestym(R)) (Releuko(R)) Chemotherapy-indu X X X ced neutropenia Acute myeloid X X X leukemia Bone marrow X X X transplantation Autologous X X peripheral blood progenitor cell collection and therapy Severe chronic X X X neutropenia Tbo-filgrastim is only indicated for use in adult and pediatric patients (>=1 month of age) with non-myeloid malignancies receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia in order to reduce the duration of severe neutropenia.
DRUG IMAGES
  • NEUPOGEN 480 MCG/1.6 ML VIAL
    NEUPOGEN 480 MCG/1.6 ML VIAL
  • NEUPOGEN 300 MCG/ML VIAL
    NEUPOGEN 300 MCG/ML VIAL
  • NEUPOGEN 300 MCG/0.5 ML SYR
    NEUPOGEN 300 MCG/0.5 ML SYR
  • NEUPOGEN 480 MCG/0.8 ML SYR
    NEUPOGEN 480 MCG/0.8 ML SYR
The following indications for NEUPOGEN (filgrastim) have been approved by the FDA:

Indications:
Chemotherapy-induced neutropenia
Congenital neutropenia
Cyclic neutropenia
Hematopoietic syndrome of acute radiation syndrome
Idiopathic neutropenia
Neutropenia secondary to AML treatment
Peripheral mobilization of hematopoietic stem cells
Prevention of neutropenia from cancer chemotherapy
Severe chronic neutropenia


Professional Synonyms:
Bone marrow syndrome of acute radiation syndrome
Congenital aleukia
Congenital leukopenia
Infantile genetic agranulocytosis
Kostmann neutropenia
Kostmann syndrome
Neutropenia due to acute myelocytic leukemia treatment
Neutropenia of unknown origin
Neutrophilic leukocytopenia from cancer chemotherapy
Neutrophilic leukopenia from cancer chemotherapy
Neutrophilopenia from cancer chemotherapy
Patient with acute exposure to myelosuppressive dose of radiation
Periodic neutropenia
Primary neutropenia