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Last Updated: November 5, 2019
Result type: Reports
Project Number: SE0588-000
Product Line: Reimbursement Review

Generic Name: pegfilgrastim

Brand Name: Fulphila

Manufacturer: BGP PHARMA ULC

Therapeutic Area: Febrile neutropenia in non-myeloid malignancies

Indications: Febrile neutropenia in non-myeloid malignancies

Manufacturer Requested Reimbursement Criteria1: Be listed as the preferred pegfilgrastim product to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Submission Type: Initial

Project Status: Complete

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 postedOctober 16, 2018
Patient group input closedDecember 04, 2018

- No patient input submission received

Submission receivedNovember 14, 2018
Submission accepted for reviewNovember 27, 2018

- Submission was not accepted for review on 21 Nov 2018

Review initiatedNovember 28, 2018
Draft CDR review report(s) sent to applicantJanuary 25, 2019
Comments from applicant on draft CDR review report(s) receivedJanuary 31, 2019
Final CDR review report(s) sent to applicantFebruary 06, 2019
Final CDR review report(s) postedFebruary 22, 2019