Regulatory Decision Summary for ZARXIO (filgrastim)
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: ZARXIO (filgrastim)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
August 06, 2019
What was the purpose of this submission?
The sponsor filed this New Drug Submission (NDS) to obtain market authorization for Zarxio (filgrastim), a proposed biosimilar biologic drug to Neupogen, for the treatment of neutropenia and for the mobilisation of autologous peripheral blood progenitor cells. The proposed indications for Zarxio were in line with those for which the Canadian Reference Biologic Drug 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?
At the time of cancellation, Health Canadas review of the submission was complete. Health Canada had identified major deficiencies in the clinical component of the NDS that would have precluded issuing an approval. Specifically, major deficiencies were identified with respect to the design and conduct of the submitted pivotal comparative pharmacokinetic/pharmacodynamic (PK/PD) study which did not allow assessment of the PK and PD (efficacy) comparability to be made. The sponsor chose to cancel their submission without prejudice to refiling at a later date.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
As Zarxio 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:
Zarxio