Regulatory Decision Summary for Pexegra
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):
pegfilgrastim
Control Number:
273871
Brand/Product Name:
Pexegra
Therapeutic Area:
L03AA13
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 New Drug Submission (NDS) was to seek market authorization for Pexegra (pegfilgrastim), a biosimilar to Neulasta (pegfilgrastim), indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
The clinical package in support of the market authorization for Pexegra demonstrated pharmacokinetic (PK) and pharmacodynamic (PD) comparability between Pexegra and Neulasta in a randomized, double-blind, single-dose, two-period crossover comparative pharmacology study in healthy subjects. Both PK and PD parameters were within the pre-defined margins.
The comparative safety and immunogenicity of Pexegra and Neulasta were assessed in a randomized, single blind, repeat-dose, two cycle, parallel-arm comparative immunogenicity study in healthy volunteers. No clinically meaningful differences in safety or immunogenicity between Pexegra and Neulasta were observed.
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical and clinical comparisons. Overall, as the evidence demonstrated similarity of Pexegra to Neulasta, the anticipated benefit outweighs the potential risks for the use of Pexegra to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
The chemistry and manufacturing information submitted for Pexegra has demonstrated that the drug substances and drug product can be consistently manufactured to meet the approved specifications. An Risk Management Plan (RMP) for Kevzara was reviewed by Health Canada and considered acceptable.
A Notice of Compliance was issued.
For further details about Pexegra, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2024-12-13
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02553945
Prescription Status:
Schedule D drug
Date Filed:
2023-10-18
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| PEXEGRA | 02553945 | JAMP PHARMA CORPORATION | PEGFILGRASTIM 10 MG / ML |