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| Project Number | pCODR 10160 |
|---|---|
| Brand Name | TBD |
| Generic Name | Trastuzumab |
| Tumour Type | Breast & Gastrointestinal |
| Indication | Breast and Gastric Cancer Biosimilar |
| Funding Request | Breast and Gastric Cancer Biosimilar |
| Review Status | File-Closed Not Submitted |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Pfizer Canada Inc. |
| Sponsor | Pfizer Canada Inc. |
| Submission Date (Target Date) | May 15, 2019 |
| Submission Type | Biosimilar – New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | May 30, 2019 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued |
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.