Last Updated : November 6, 2019
Details
FilesGeneric 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
- 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 posted | October 16, 2018 |
| Patient group input closed | December 04, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | November 14, 2018 |
| Submission accepted for review | November 27, 2018 |
| Clarification: - Submission was not accepted for review on 21 Nov 2018 | |
| Review initiated | November 28, 2018 |
| Draft CDR review report(s) sent to applicant | January 25, 2019 |
| Comments from applicant on draft CDR review report(s) received | January 31, 2019 |
| Final CDR review report(s) sent to applicant | February 06, 2019 |
| Final CDR review report(s) posted | February 22, 2019 |
Files
Last Updated : November 6, 2019