Regulatory Decision Summary for Fulphila
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 provide the response to the Notice of Deficiency (NOD) previously issued for Fulphila (pegfilgrastim) New Drug Submission (NDS). After evaluation of the submitted data package, Health Canada authorized Fulphila, as a biosimilar to the Canadian authorized Neulasta for the indication 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?
Similarity of Fulphila to Neulasta was supported by 3 randomized comparative clinical studies. A double-blind, 3-period, 3 treatments, 3-way crossover single dose (2 mg) PK/PD study in healthy volunteers (n = 216) evaluated the similarity in pharmacokinetics (PK) and pharmacodynamics (PD) of Fulphila to the EU-Neulasta (which was accepted as a proxy for the Canadian reference) and the US-Neulasta in healthy volunteers. All primary PK and PD parameters were within the pre-defined acceptable range of 80 - 125% for each of 3 comparisons between Fulphila, EU-Neulasta and US-Neulasta based on 90% confidence intervals (CIs) for PK parameters and 95% CIs for PD parameters. A validated PD marker-absolute neutrophil account (ANC) was used in this study.
The similarity in immunogenicity between Fulphila and the US-Neulasta was investigated by a randomized, open label, 2-dose (6 mg each), parallel study in healthy volunteers (n = 50). The results showed that there were no clinically meaningful differences between Fulphila and the US-Neulasta in the immunogenicity profile. The comparability between the reference drug (the EU-Neulasta) and the US-Neulasta was established in the head-to-head quality comparison and the above mentioned 3-way cross-over single dose PK/PD study in healthy volunteers.
The safety comparisons of Fulphila to EU-Neulasta were also studied in a randomized, double-blind, multicenter trial for the prevention of neutropenia in patients with Stage II/III breast cancer receiving 6 cycles of TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy in the neoadjuvant or adjuvant settings (n = 194). No clinically meaningful differences in safety and immunogenicity between Fulphila and Neulasta were observed. The safety profiles of both groups were consistent with the known safety profile in patients treated with Neulasta.
The final decision for this product was based on the totality of evidence, including comparative structural, functional, non-clinical, PK/PD and clinical comparisons. The benefit/risk profile of Fulphila as a biosimilar biologic drug to the Canadian authorized Neulasta is considered positive for the indication which has been authorized for Neulasta.
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 |
|---|---|---|---|
| FULPHILA | 02484153 | BIOSIMILAR COLLABORATIONS IRELAND LIMITED | PEGFILGRASTIM 10 MG / ML |