Table 2.
Summary of studies with biosimilar G-CSF in healthy donors undergoing allogeneic PBSC mobilization
| Study design and number of donors | Mean/median duration of G-CSF (days) | Mean/median number of leukapheresis procedures | Mean/median number of CD34+ cells mobilized by body weight (×106/kg) | Mean/median number of CD34+ cells mobilized in PB (×1012/L) | Safety/AEs |
|---|---|---|---|---|---|
| Prospective noncomparative study of biosimilar (n = 48), ∼5 μg/kg43 | Biosimilar, 16 (10-28) (until ANC recovery, >0.5 × 109/L) | Biosimilar, 1-3 | Biosimilar, 6.1 | NA | NA |
| Prospective study of biosimilar (n = 21), 10 μg/kg46 | Biosimilar, 5 (4-7) | Biosimilar, 1.5 (1-3) | Biosimilar, 6.0 (2.6-9.2) | Biosimilar, 72 (16-145) | Bone pain, n = 8 |
| Prospective comparative study of biosimilar (n = 9) vs. historical originator (n = 9), 5 μg/kg47 | Biosimilar, 5 (5-6) | Biosimilar, 1 (1-2) | Biosimilar, 7.2 (4-9.2) Originator, 9.0 (6-14.3) (p = 0.12) | Biosimilar, 70.2 (24-114) × 109/L Originator, 86.3 (42.3-146.4) × 109/L | Mild bone or muscle pain in all patients in both groups |
| Prospective comparative study of biosimilar (n = 11) vs. originator (n = 11), 10 μg/kg48 | Biosimilar, 5 (5-6) Originator, 5 (5-6) | Biosimilar, 1.45* Originator, 1.27* | Biosimilar, 4.4 (2.0-7.3) Originator, 4.2 (2.1-7.9) | Biosimilar, 65.8 (19.3-114.6) mm3 Originator, 50.9 (13.6-122.4) mm3 | 6/11 donors reported arthralgias in both groups |
| Prospective long-term study of biosimilar (n = 84), 10 μg/kg49 | Biosimilar, 5 (5-6) | Biosimilar, 1 (1-2) | Biosimilar, 9.5 (4.6-19.9) | Biosimilar, 111 (34-284) | Bone pain, 89% Headache, 29% Back pain, 12% |
*
Ranges not provided. In all studies, biosimilar is Zarzio, except Schmitt et al.,48 in which they used Tevagrastim.
ANC = absolute neutrophil count; NA = data not available.