Regulatory Decision Summary for Niopeg

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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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?

Nora Pharma Inc. filed a New Drug Submission (NDS) for Niopeg (pegfilgrastim solution, 10 mg/mL) in pre-filled syringe for subcutaneous (SC) administration, as a biosimilar to the Canadian Reference Biologic Drug, Neulasta (pegfilgrastim solution, 10 mg/mL, in pre-filed syringe). Niopeg is intended for the same indication that is currently authorized to Neulasta in Canada, i.e., 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?

To support the biosimilarity of Niopeg to Neulasta, comparative structural, functional, non-clinical, clinical pharmacokinetic (PK) and pharmacodynamic (PD), and clinical efficacy and safety results between Niopeg and Neulasta were provided.

The non-clinical comparative studies demonstrated that there were no differences in the pharmacodynamic, toxicokinetic and toxicological effects of Niopeg compared to the reference product Neulasta. All findings were attributed to the pharmacodynamic effects of Pegfilgrastim and were comparable between the test product and Neulasta.

When a 6 mg single dose of pegfilgrastim Niopeg or Neulasta was administered in healthy adult subjects in a two-way, cross-over study, the results showed comparable PK profiles between Niopeg and Neulasta. Specifically, the relative mean Cmax and 90% confidence interval (CI) of relative mean area under the concentration versus time curve to the time of the last quantifiable concentration (AUCT) of Niopeg to Neulasta were within the acceptance margins of 80.0%-125.0%. Comparable PD parameters between the two products were also demonstrated. A supportive comparative PD study also established comparable PD profiles between Niopeg and Neulasta when a single dose of 2 mg pegfilgrastim was administered subcutaneously in adult healthy subjects.

Comparable efficacy, safety and immunogenicity between the two products were also demonstrated in a randomized, assessor-blinded, parallel-group phase 3 trial in breast cancer patients undergoing adjuvant myelosuppressive chemotherapy therapy after surgical dissection of breast cancer. The primary efficacy analysis showed that the 95% CI of the mean ratio for the duration of severe neutropenia (DSN) between Niopeg and Neulasta treatment arms was entirely contained within the pre-define equivalence margins of 0.65 - 1.55.

No clinically meaningful differences in the safety profiles between Niopeg and Neulasta were observed in healthy subjects or in patients with breast cancer. No new safety signal was detected. The immunogenicity findings confirmed the low immunogenic potential of Niopeg and were consistent with the know immunogenicity profile of Neulasta.

The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical and clinical comparative pharmacodynamic comparisons. Overall, as the evidence demonstrated similarity of Niopeg to Neulasta, the anticipated benefit outweighs the potential risks for the use of Niopeg.

An updated Risk Management Plan (RMP) for Niopeg was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Niopeg has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Niopeg for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Niopeg, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

Date of Decision:



Nora Pharma

Drug Identification Number(s) Issued:


Prescription Status:

Available by prescription only

Date Filed: