Biosimilar Filgrastim Proves Noninferior to Reference in PBCM

Samantha DiGrande

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

Data were collected from 52 patients undergoing PBSC collection at a health system in Edinburgh, Scotland, between March 2017 and February 2018. All patients were mobilized with biosimilar filgrastim subcutaneously at a dose of 5 µL/kg beginning after chemomobilization and continuing until PBSC collection was completed. Stem cell collection was initiated when peripheral blood CD34 cells exceeded 15 µL.

Many different disease states were included within the trial, and the indication for stem cell mobilization included patients with non-Hodgkin lymphoma (n = 24, 46%), multiple myeloma (n = 21, 40%), Hodgkin lymphoma (n = 2, 4%), germ cell tumors (n = 5, 10%).

In total, 71% of patients mobilized with biosimilar filgrastim required only 1 leukapheresis procedure, compared with 50% of patients mobilized with the reference. Additionally, 49% of patients who were mobilized with biosimilar filgrastim achieved their target CD34 yield 24 hours after the planned day of first collection.

Researchers found that biosimilar filgrastim was non-inferior to the reference product in terms of achieving CD34 yield. The study’s authors also noted that delaying the first day of collection by 24 hours may result in a more cost-effective and efficient collection process.

The European market has years of experience with biosimilars. In the European Union, there are currently 7 biosimilar filgrastim options on the market. Conversely, in the United States, biosimilars have only been available since 2015. As such, there are only 2 FDA-approved biosimilar filgrastim products on the market to date.

Reference

Elamin FE, Manson, L. Use of biosimilar filgrastim for peripheral blood stem cell mobilization: a single centre experience in UK. Presented at the Annual Scientific Meeting of the British Blood Transfusion Society October 3-5, 2018, United Kingdom. Abstract PO122. onlinelibrary.wiley.com/doi/epdf/10.1111/tme.12558.