Regulatory Decision Summary for Filra
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
Control Number:
273870
Brand/Product Name:
Filra
Therapeutic Area:
Immunostimulants
Type of Submission:
New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this submission was to seek market authorisation for Filra (filgrastim), a biosimilar to Neupogen, the reference biologic drug in Canada, for all of the indications currently authorized to Neupogen.
Why was the decision issued?
The clinical package in support of the market authorization for Filra was based on a single dose, crossover, comparative pharmacokinetics (PK)/pharmacodynamics (PD) study between Filra and Neupogen, and a parallel, multiple dose comparative immunogenicity study conducted in healthy adult subjects.
Based on the single dose pivotal PK/PD study, PK and PD comparability was demonstrated. Both PK and PD parameters were within the pre-defined margins. In addition, no subject had treatment-emergent anti-drug antibodies from either Filra or Neupogen in the multiple dose immunogenicity study conducted in healthy adult subjects.
The safety profile of Filra is generally consistent with the known safety profile of Neupogen. No clinically meaningful differences in safety and immunogenicity profiles were observed between Filra and Neupogen. The known risks of Neupogen have been included in the Product Monograph (PM) for Filra.
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, PK/PD and clinical comparisons. Therefore, the benefit-risk profile of Filra is considered favourable for the indications currently held by the Canadian reference product, Neupogen.
An updated Risk Management Plan (RMP) for Filra was reviewed by Health Canada and considered acceptable.
Overall, the results of the biosimilarity studies demonstrate that Filra is highly similar to United States (US)-Neupogen and confirm that Filra meets the necessary quality standards to be recognized as a biosimilar of Neupogen. In addition, process validation data demonstrate that the established Filra manufacturing processes are capable of consistently manufacturing Filra drug substance and drug product that meet the pre-defined specifications and quality attributes.
The Package labels, Package Insert and Brand Name information submitted for Filra met all applicable regulations and guidance.
A Notice of Compliance was recommended.
For further details about Filra, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2025-03-24
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02556537
02556545
Prescription Status:
Available by prescription only
Date Filed:
2024-02-25
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| FILRA | 02556537 | JAMP PHARMA CORPORATION | FILGRASTIM 300 MCG / 0.5 ML |
| FILRA | 02556545 | JAMP PHARMA CORPORATION | FILGRASTIM 480 MCG / 0.8 ML |