Regulatory Decision Summary for Nypozi
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 submission was to seek market authorisation for Nypozi as a biosimilar to Neupogen, the reference biologic drug in Canada, on the basis of comparative quality, non-clinical and clinical studies. A Notice of Compliance was issued for Nypozi with all indications authorised for the reference biologic drug in Canada.
Why was the decision issued?
The authorization was based on comparable pharmacokinetics/pharmacodynamics (PK/PD) between Nypozi and Neupogen in a single dose comparative PK/PD study and, a multiple dose comparative PD study conducted in healthy subjects.
For the single dose study, PK comparability was demonstrated as the ratio of geometric means (GMR) for Cmax and the 90% Confidence Interval (CI) for the AUC0-last were within the equivalence margin of 80.0% to 125.0% for measured (potency uncorrected) data. Pharmacodynamic (PD) comparability (absolute neutrophil count [ANC] as the relevant PD marker for the activity of G-CSF) was also demonstrated as the 95% Confidence Interval (CI) for the AUECANC and ANCmax parameters were within the equivalence margins of 80.0% to 125.0%.
For the multiple dose study, PD comparability (CD34+ count as the relevant PD marker to support the hematopoietic progenitor cell mobilization indication) was demonstrated as the 95% Confidence Interval (CI) for the AUECCD34+ and CD34+max parameters were within the equivalence margins of 80.0% to 125.0%.
In addition, in terms of immunogenicity, Nypozi was demonstrated to be non-inferior to Neupogen in a parallel arm, multiple dose non-inferiority study conducted in healthy volunteers.
The safety profile of Nypozi is generally consistent with the known safety profile of Neupogen. No new safety signals were observed in healthy volunteers from the submitted clinical studies. The known risks of Neupogen have been included in the Product Monograph (PM) for Nypozi. The Contraindications, Serious Warnings and Precautions box, Warnings and Precautions, and Adverse Reactions sections from Neupogen are retained in the PM for Nypozi.
The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical, PK/PD and clinical comparisons. Furthermore, the scientific rationale provided by the Sponsor to support the authorization of Nypozi for all indications held by the reference biologic drug is considered adequate and is in line with Health Canada’s biosimilar guidance document. Therefore, the benefit-risk profile of Nypozi is considered favourable for the indications, doses and routes of administration for which the Canadian reference product, Neupogen, are licensed and are recommended to be granted to Nypozi.
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 |
|---|---|---|---|
| NYPOZI | 02521008 | TANVEX BIOPHARMA USA, INC. | FILGRASTIM 480 MCG / 0.8 ML |
| NYPOZI | 02520990 | TANVEX BIOPHARMA USA, INC. | FILGRASTIM 300 MCG / 0.5 ML |