Regulatory Decision Summary for Lapelga
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 for Lapelga (pegfilgrastim), a Neulasta biosimilar, indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. This submission relied on demonstrating similarity to the Canadian authorized reference product, Neulasta.
Why was the decision issued?
The similarity of Lapelga to Neulasta has been established based on comparative analytical and functional, non-clinical, PK/PD and clinical studies. From a clinical perspective, the sponsor provided evidence of comparable pharmacokinetic and pharmacodynamic activity of Lapelga and Neulasta in a healthy volunteer comparative two-way crossover study. The sponsor demonstrated that the ratios of the geometric means for Lapelga/Neulasta (test/reference) were within the pre-specified acceptance range of 80-125% for AUCt and Cmax and the 90% confidence interval of the geometric mean ratio for AUCt was also within this acceptance range, as a measure of pharmacokinetic similarity between Lapelga and Neulasta. For pharmacodynamic comparisons, the area under the effect curve for absolute neutrophil counts from time zero measured up to the last sampling time (AUECt), as well as the maximum effect concentration (Emax), were determined for Lapelga and Neulasta. The ratios of the geometric means for Lapelga/Neulasta for AUECt and Emax and the 95% confidence interval of the geometric mean ratio for AUECt were also within the pre-defined acceptance range of 80 - 125% as a measure of pharmacodynamic similarity.
The safety and immunogenicity comparisons of Lapelga to Neulasta were assessed in a randomized, assessor blinded, active controlled study in patients with early breast cancer receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in the adjuvant setting. No clinically meaningful differences in safety and immunogenicity between Lapelga and Neulasta were observed. On the basis of these results, and considering the similarity demonstrated in comparative structural, functional, and non-clinical studies, the totality of data supports the authorization of Lapelga for the same indication as Neulasta.
As the evidence demonstrated similarity of Lapelga to Neulasta, the benefit/risk assessment for Lapelga is considered positive. A Notice of Compliance was issued.
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 |
|---|---|---|---|
| LAPELGA | 02474565 | APOTEX INC | PEGFILGRASTIM 6 MG / 0.6 ML |