Regulatory Decision Summary for Truxima
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Cancellation for Opdivo (Control number 204349)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
NOC - IP Hold as of March 25, 2019
Date of cancellation
2019-03-14
What was the purpose of this submission?
The sponsor filed this NDS to obtain market authorization for Truxima (rituximab), a proposed biosimilar biologic drug to Rituxan, for use in patients with certain types of Non-Hodgkins lymphoma and Chronic lymphocytic leukemia for which the Canadian reference product is currently authorized.
What did the company submit to support its submission?
The sponsor submitted quality, clinical and labelling components.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
Health Canadas review of the submission was complete at the time of cancellation. The assessment recommended a Notice of Compliance (NOC). The NOC was on intellectual property (IP) hold in accordance with the Patented Medicines (Notice of Compliance) Regulations.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
As Truxima is a proposed biosimilar biologic drug to a product that is marketed in Canada, there are no foreseen impacts on patients accessing the drug through the SAP or via clinical trials.
Additional information
*Proposed Brand Name
Truxima