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filgrastim

Last Updated: May 17, 2019
Result type: Reports
Project Number: SE0585-000
Product Line: Common Drug Review

Generic Name: filgrastim

Brand Name: TBC

Manufacturer: Pfizer Canada Inc.

Indications: Prevention or treatment of neutropenia in various indications

Manufacturer Requested Reimbursement Criteria1: Listed in accordance with the Health Canada approved indications, in a similar manner to other biosimilar filgrastim products in CanadaCancer Patients Receiving Myelosuppressive ChemotherapyTo decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. Nivestym is indicated in adult and pediatric patients with cancer receiving myelosuppressive chemotherapy. Patients with Acute Myeloid LeukemiaFor the reduction in the duration of neutropenia, fever, antibiotic use and hospitalization, following induction and consolidation treatment for acute myeloid leukemia. Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow TransplantationTo reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in patients undergoing myeloablative therapy followed by bone marrow transplantation. Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and TherapyFor the mobilization of autologous peripheral blood progenitor cells in order to accelerate hematopoietic recovery by infusion of such cells, supported by Nivestym, after myelosuppressive or myeloablative chemotherapy. Patients with Severe Chronic Neutropenia (SCN)For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infection in patients with a diagnosis of congenital, cyclic or idiopathic neutropenia. Patients with HIV InfectionIn patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal ANC (i.e. between 2 x 109 and 10 x 109/L).

Submission Type: New

Project Status: Cancelled

Biosimilar: Yes

Companion Diagnostics: No

Fee Schedule: Schedule D

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input posted October 03, 2018
Patient group input closed November 22, 2018
Clarification:

- No patient input submission received

Submission received November 01, 2018
Submission accepted for review November 08, 2018
Review initiated November 09, 2018
Clarification:

- Submission temporarily suspended pending receipt of information

- Submission was cancelled by CADTH on 31 May 2019 as the biosimilar review process has been discontinued