Regulatory Decision Summary for Ruxience
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 Ruxience (Control number 224672)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. Pfizer Canada ULC cancelled the submission before a final decision was issued due to an internal business decision.
Date of cancellation
2019-04-02
What was the purpose of this submission?
Pfizer Canada ULC filed a New Drug Submission to propose Ruxience (rituximab) as a biosimilar to the Canadian reference product Rituxan. The proposed indications were based on limited information from the Rituxan Product Monograph (PM).
What did the company submit to support its submission?
Pfizer Canada ULC submitted clinical, quality, 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?
At the time of the cancellation, the clinical, quality and labelling reviews were pending.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
This decision is not expected to impact the Special Access Programme (SAP) or via clinical trials.
Additional information
*Proposed Brand Name
Ruxience
For more information on Health Canadas decision, please view the Summary Basis of Decision.