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Trastuzumab for Breast and Gastric Cancer Biosimilar – Details

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 Deemed Complete
Submission Type Biosimilar – New Drug
Stakeholder Input Deadline (target date based on target submission date) ‡ May 30, 2019
Final Biosimilar Summary Dossier Issued (target date)

‡ 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.