Summary of Cancellation for Zefylti
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:
Contact:
Medicinal ingredient(s):
Filgrastim
Therapeutic area:
Immunostimulants
Type of submission:
New Drug Submission
Control number:
267597
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2024-08-01
What was the purpose of this submission?
The purpose of this submission was to seek the authorization of Zefylti (filgrastim, 600 mcg/mL, i.e. 300 mcg filgrastim in 0.5 mL solution in a pre-filled syringe [PFS]), a biosimilar to Neupogen (filgrastim, 600 mcg/mL, PFS), for all indications currently authorized to the reference biologic drug Neupogen in Canada.
What did the company submit to supports its submission?
The sponsor submitted drug quality, biosimilarity, and clinical components. The clinical pharmacokinetics and pharmacodynamics comparability study consisted of a double-blind, randomized, parallel, controlled study comparing Zefylti (300 mcg in 0.5 mL solution]) with the European Union-sourced Neupogen (480 mcg in 0.5 mL solution).
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission had begun. Health Canada had identified some deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel their submission in order to re-file at a later date with additional data.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials. For more information about the Special Access Programme refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas.
*Proposed Brand Name:
Zefylti
Manufacturer:
Curateq Biologics Private Limited
Drug Identification Numbers issued:
N/A
Date filed:
2022-09-07