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Rituximab (Truxima) for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar - Details

Project Number pCODR 10184
Brand Name Truxima
Generic Name Rituximab
Strength 10 mg/mL
Tumour Type Lymphoma & Leukemia
Indication Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia Biosimilar
Funding Request Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Review Status File-Closed Not Submitted
Pre Noc Submission No
NOC Date April 4, 2019
Manufacturer Teva Canada Innovation
Sponsor Teva Canada Innovation
Submission Date (Target Date) May 22, 2019
Submission Type Biosimilar – New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ June 5, 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.