Last Updated : November 6, 2019
Details
FilesGeneric 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
- 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 | December 14, 2017 |
| Patient group input closed | February 09, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | February 23, 2018 |
| Submission accepted for review | March 02, 2018 |
| Review initiated | March 05, 2018 |
| Draft CDR review report(s) sent to applicant | April 19, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 24, 2018 |
| Final CDR review report(s) sent to applicant | April 30, 2018 |
| Final CDR review report(s) posted | May 08, 2018 |
Files
Last Updated : November 6, 2019