pegfilgrastim

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Generic Name:
pegfilgrastim
Project Status:
Complete
Therapeutic Area:
Febrile neutropenia in non-myeloid malignancies
Manufacturer:
BGP PHARMA ULC
Call for patient/clinician input open:
Brand Name:
Fulphila
Project Line:
Reimbursement Review
Project Number:
SE0588-000
Call for patient/clinician input closed:
Biosimilar:
Yes
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
Fee Schedule:
Schedule D
Indications:
Febrile neutropenia in non-myeloid malignancies
Recommendation Type:
N/A
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedOctober 16, 2018
Patient group input closedDecember 04, 2018
Clarification:

- No patient input submission received

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

- 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