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|Project Number||pCODR 10158|
|Strength||100 mg and 400 mg|
|Tumour Type||Gastrointestinal / Lung|
|Indication||Metastatic Colorectal Cancer / Non-Small Cell Lung Cancer Biosimilar|
|Funding Request||For first-line treatment of patients with metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine based chemotherapy / For treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer, in combination with carboplatin/paclitaxel chemotherapy regimen|
|Review Status||Final Biosimilar Dossier Issued|
|Pre Noc Submission||No|
|NOC Date||April 30, 2018|
|Manufacturer||Amgen Canada Inc.|
|Sponsor||Amgen Canada Inc.|
|Submission Date||October 3, 2018|
|Submission Deemed Complete||October 18, 2018|
|Submission Type||Biosimilar – New Drug|
|Stakeholder Input Deadline ‡||October 18, 2018|
|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.