Regulatory Decision Summary for Nyvepria
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.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization of Nyvepria (pegfilgrastim), a biosimilar to the reference biologic drug Neulasta, for the same indication and use currently held by Neulasta in Canada. After evaluation of the submitted data package, Health Canada authorized Nyvepria to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
Why was the decision issued?
The clinical data package in support of the market authorization for Nyvepria demonstrated PK and PD comparability between Nyvepria and Neulasta in a 3-way single-dose cross-over design study conducted in healthy volunteers. Both PK and PD parameters were within the pre-defined margins of 80.0% to 125.0%. Furthermore, immunogenicity between Nyvepria and Neulasta was compared in a 2-dose parallel study conducted in healthy volunteers. Results showed that Nyvepria was non-inferior to Neulasta in term of immunogenicity.
The safety profile of Nyvepria is generally consistent with that of the reference product Neulasta. There was no particular treatment-emergent adverse events (TEAEs) that would raise specific concerns, and the numerical differences in some TEAEs observed between the 2 treatment arms are considered to be not clinically relevant, and are not expected to impact the comparability assessment between the two products. The known risks associated with Neulasta are captured in the Nyvepria Product Monograph.
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic/pharmacodynamic (PK/PD) and clinical comparisons. Therefore, Nyvepria is considered to have a risk benefit profile that is favourable. A Notice of Compliance was recommended.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| NYVEPRIA | 02506238 | PFIZER CANADA ULC | PEGFILGRASTIM 6 MG / 0.6 ML |