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|Project Number||pCODR 10169|
|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|
|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|
|Stakeholder Input Deadline ‡||January 9, 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.