Regulatory Decision Summary for GRASTOFIL

Neupogen (filgrastim) has been authorized in Canada since 2002 and has been proven to be safe and effective in adult and pediatric (>18 years of age) cancer patients who receive chemotherapy and in patients with neutropenia.

This New Drug Submission (NDS) was submitted to support the authorization of Grastofil, a subsequent entry biologic (SEB) to Neupogen, on the basis of comparative physicochemical, biological and clinical studies. Pharmacokinetic and pharmacodynamic comparability has been satisfactorily demonstrated in healthy volunteers. Three clinical studies in healthy volunteers have also demonstrated that Grastofil has a comparable safety profile and is comparable in increasing absolute neutrophil counts (ANC), an indicator for efficacy. A single arm, non-comparable clinical study in breast cancer patients shows that the safety profile of Grastofil is consistent with what has been observed with Neupogen. In addition, based on the scientific rationales and linearity of the reference product with subcutaneous (SC) route of administration, and the clinical experience with the reference product, it is considered to be adequate to support extrapolation to all indications granted to Neupogen in accordance with the principles of extrapolation as outlined in the Canadian guidance document: Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Based on the totality of the data submitted and a thorough assessment, the benefit/risk assessment for Grastofil in each of the requested indications, is considered positive.