TABLE 1.
Summary of studies with biosimilar G-CSF in patients undergoing autologous PBSC mobilization
| Study design and number of patients | Mean/median duration of G-CSF (days) | Mean/median number of leukapheresis* | 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 comparative study of biosimilar (n = 40) vs. historical originator (n = 41) (5 or 10 μg/kg)34 | Biosimilar, 5 (5-12) Originator, 5 (5-9) (p = 0.62) | Biosimilar, 1 (1-3) Originator, 1 (1-3) (p = 0.10) | Biosimilar, 5.50 (1.1-20) Originator, 4.49 (0.9-25) (p = 0.26) | Biosimilar, 55.5 (1-196) Originator, 60.0 (13-432) (p = 0.71) | Bone pain and/or headache: Biosimilar 5 μg, n = 3 Biosimilar 10 μg, n = 11 Originator, NA |
| Prospective comparative study of biosimilar (n = 54) vs. originator (n = 54) (10 g/kg)35 | Biosimilar, 8 (4-17) Originator, 8 (4-14) | Biosimilar, 1 Originator, 1 | Biosimilar, 9.1 (0-23) Originator, 9.4 (6-48) | Biosimilar, 62.0 (2-394) Originator, 47.5 (2-370) | Bone pain: Biosimilar, n = 8; originator, n = 6 Neutropenic fever: Biosimilar, n = 9; originator, n = 11 |
| Prospective comparative study of biosimilar (n = 55) vs. originator (n = 35), 5 μg/kg36 | Biosimilar, 12 (10-13) Originator, 12 (10-21) (until ANC recovery, >0.5 × 109/L) | Biosimilar, NA Originator, NA | Biosimilar, 6.7 ± 3 Originator, 3.9 ± 3 | Biosimilar, NA Originator, NA | Infections (Grade 3 or 4) Biosimilar, n = 9; originator, n = 11 (p = 0.09) Neutropenic fever: Biosimilar, n = 3; originator, n = 7 (p = 0.03) |
| Prospective comparative multicenter study of biosimilar (n = 38) vs. historical originator (n = 50)37 | Biosimilar, 7 (4-12)‡ 7.8 (1-16)‡ Originator, 7.5 (6-10)‡ 6.9 (5-9)‡ | Biosimilar, NA Originator, NA | Biosimilar, 4 (1.3-7.36)‡ 3.2 (2.24-5.03)‡ Originator, 3.8 (1.74-12.3)‡ 3.6 (1.61-7.35)‡ | NA | Biosimilar, one patient died from transplantation-related mortality Originator, NA |
| Retrospective noncomparative study of biosimilar (n = 23)38 | Biosimilar, 14.4 (6-23) | NA | Biosimilar, 10.1 ± 4 | NA | Neutropenic events: Biosimilar, n = 5 |
| Prospective noncomparative multicenter study of biosimilar (n = 21), 10 μg/kg39 | Biosimilar, 12 (9-27) | NA | Biosimilar, 5.83 (2.22-24.7) | Biosimilar, 51 (8-393) | NA |
| Prospective comparative single-center study of biosimilar (n = 26) vs. historical originator (n = 48), 10 μg/kg40 | Biosimilar, 16.5 (11-44) Originator, 15.0 (9-23) (p = 0.078) (until neutrophil engraftment, >500/μL) | NA | Biosimilar, 9.7 Originator, 8.0 (p = 0.437) | Biosimilar, 92 × 106/L (Day 5) Originator, 88 × 106/L (Day 5) (p = 0.713) | The occurrence and intensity of bone pain was similar in both groups |
| Prospective study of biosimilar (n = 44), 5 μg/kg bd41 | Biosimilar, 8.2† | Biosimilar, 1.45† | Biosimilar, 4.3 (0.8-6.2)/kg | Biosimilar, 58.3 (10-503.5) | NA |
| Retrospective comparative study of biosimilar (n = 154) vs. historical originator (n = 131)42 | Biosimilar, NA Originator, NA | Biosimilar, 1 (1-4) Originator, 1 (1-4) | Biosimilar, 4.5 (0.2-43)/kg Originator, 4.4 (0.5-56)/kg | Biosimilar, 0.038 (0-0.516) × 109/L Originator, 0.031 (0.002-0.802) × 109/L | NA |
| Retrospective comparative study of biosimilar (n = 104) vs. historical lenograstim (n = 155), ∼5 μg/kg43 | Biosimilar, 13-14§ Lenograstim, 12-13§ (until ANC recovery, >0.5 × 109/L) | Biosimilar, 1-2 (1-3)§ Lenograstim, 1-2 (1-3)§ | Biosimilar, 3.9-8.7 (0.5-29.9)§ Lenograstim, 3.1-5.1 (1.1-33.7)§ | Biosimilar, 25.9-66.7 (6.6-577.7)§ Lenograstim, 20.5-32.5 (5.1-412.9)§ | NA |
| Prospective comparative study of biosimilar (n = 10) vs. historical originator (n = 10), 15 μg/kg44 | Biosimilar, 12 (10-16) Originator, 14 (10-17) (time to white blood cell engraftment) | Biosimilar, 1 (1-3) Originator, 1 (1-2) | Biosimilar, 4.10 (0.25-4.84) Originator, 2.71 (1.22-10.3) | NA | |
| Prospective comparative study of biosimilar (n = 36) vs. historical originator (n = 36), 5 or 10 μg/kg45 | Biosimilar, 5 (5-6) Originator, 5 (5-6) | Biosimilar, 1 (1-3) Originator, 1 (1-3) | Biosimilar, 4.76 (2.04-13.42) Originator, 4.36 (1.04-10.98) (p = NS) | Biosimilar, 58.8 (3.2-256.5) Originator, 31.3 (1.8-119.1) (p = 0.01) | Mild bone or muscle pain in both groups |
*
Ranges not provided.
†
Doses not provided.
‡
For lymphoma and myeloma patients, respectively.
§
Depending on indication and age: lymphoma or myeloma patients aged less than and 60 or more years. In myeloma patients less than 60 years old, all variables were significantly superior in the biosimilar group compared with lenograstim, including the need for one rather than two apheresis procedures. In all studies, biosimilar is Zarzio, except in Ianotto et al.,37 where it was not defined, and Publicover et al.,42 who used Ratiograstim.
ANC = absolute neutrophil count; NA = data not available; NS = non significant; PB = peripheral blood.