Regulatory Decision Summary for Armlupeg

The purpose of this New Drug Submission (NDS) was to seek market authorization for Armlupeg (pegfilgrastim), a biosimilar to Neulasta (pegfilgrastim), indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

The clinical package in support of the market authorization for Armlupeg demonstrated pharmacokinetic (PK) and pharmacodynamic (PD) comparability between Armlupeg and Neulasta in a randomized, two-period, cross-over study in healthy volunteers. Both PK and PD parameters were within the pre-defined margins.

The comparative safety and immunogenicity of Armlupeg and Neulasta were assessed in healthy volunteers and in a randomized, open-label study in breast cancer patients receiving myelosuppressive chemotherapy. No clinically meaningful differences in safety or immunogenicity between Armlupeg and Neulasta were observed.

The final decision for this product was based on the totality of evidence, including structural, functional, non-clinical and clinical comparisons. Overall, as the evidence demonstrated similarity of Armlupeg to Neulasta, the anticipated benefit outweighs the potential risks for the use of Armlupeg to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. A Notice of Compliance was issued.

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