Regulatory Decision Summary for Pelmeg
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.
Product type:
Summary of Cancellation: Pegfilgrastim (*Pelmeg)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
2021-07-20
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization for Pelmeg, a proposed 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 (Amgen Inc.).
What did the company submit to support its submission?
The sponsor submitted a nonclinical data package, which included pharmacokinetic (PK), pharmacology, and toxicology program elements. In vitro primary biofunctional assays were also conducted as part of the analytical comparability package.
The clinical development program consisted of 2 pivotal studies:
- A pivotal pharmacokinetic (PK) study in healthy volunteers. The 94.32% confidence intervals (CIs) of the PK parameters (AUCT, and Cmax [as point estimate]) were within the acceptance margins of 80.0% to 125.0%. The PK study was supported by additional PK-related data in healthy volunteers administered a sub-clinical dose.
- A pivotal comparative pharmacodynamic, safety and immunogenicity study conducted among healthy volunteers. The primary analysis demonstrated that the 95% CI of the geometric means of the ANC-AUECT (a measure of the neutrophil response over time) for Pelmeg vs. Neulasta were fully contained within the predefined margins of 80 – 125%. The study also found no evidence of clinically meaningful differences in immunogenicity, and the safety profiles were considered comparable.
A scientific rationale, provided to support the authorization of Pelmeg in the proposed indication, was considered in accordance with Health Canadas biosimilar guidance document, and was considered satisfactory.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the clinical data package was complete. However, Health Canada identified deficiencies in the chemistry and manufacturing data that led to the issuance of a Notice of Deficiency. Consequently, the sponsor cancelled the submission with the option of re-filing at a later date with additional data.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Additional information
*Proposed Brand Name:
Pelmeg