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Ogivri for Early Breast Cancer / Metastatic Breast Cancer / Metastatic Gastric Cancer Biosimilar – Details

Project Number pCODR 10169
Brand Name Ogivri
Generic Name Trastuzumab
Strength 150 mg/vial and 440 mg/vial
Tumour Type Breast / Gastrointestinal
Indication Early Breast Cancer / Metastatic Breast Cancer / Metastatic Gastric Cancer Biosimilar
Funding Request For the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, following surgery and after chemotherapy, following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel, in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin / the treatment of patients with MBC whose tumours overexpress HER2 / in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease
Review Status Withdrawn
Clarification Mylan Canada has requested a voluntary withdrawal of the pCODR 10169 submission for Ogivri.
Pre Noc Submission Yes
NOC Date May 7, 2019
Manufacturer BGP Pharma ULC
Sponsor BGP Pharma ULC
Submission Date December 18, 2018
Submission Deemed Complete January 9, 2019
Submission Type Biosimilar – New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ January 9, 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.