Pegfilgrastim

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Generic Name:
Pegfilgrastim
Project Status:
Complete
Therapeutic Area:
Febrile neutropenia
Manufacturer:
Apobiologix
Call for patient/clinician input open:
Brand Name:
Lapelga
Project Line:
Reimbursement Review
Project Number:
SE0555-000
Call for patient/clinician input closed:
Biosimilar:
Yes
Manufacturer Requested Reimbursement Criteria1:
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
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 postedDecember 14, 2017
Patient group input closedFebruary 09, 2018
Clarification:

- No patient input submission received

Submission receivedFebruary 23, 2018
Submission accepted for reviewMarch 02, 2018
Review initiatedMarch 05, 2018
Draft CDR review report(s) sent to applicantApril 19, 2018
Comments from applicant on draft CDR review report(s) receivedApril 24, 2018
Final CDR review report(s) sent to applicantApril 30, 2018
Final CDR review report(s) postedMay 08, 2018