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Efficacy of three filgrastim‐intended copies for hematopoietic stem cell mobilization in healthy adult and pediatric donors in Mexico
Author(s) -
GómezDe León Andrés,
BugarinEstrada Emmanuel,
ColungaPedraza Perla R.,
ColungaPedraza Julia E.,
SalazarRiojas Rosario,
ValdésGalván Mayra,
LópezGarcía Yadith K.,
LópezGarza Mariana,
GutiérrezAguirre César H.,
CantúRodríguez Olga G.,
MancíasGuerra Consuelo,
GonzálezLlano Oscar,
GómezAlmaguer David
Publication year - 2019
Publication title -
journal of clinical apheresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.697
H-Index - 46
eISSN - 1098-1101
pISSN - 0733-2459
DOI - 10.1002/jca.21707
Subject(s) - filgrastim , medicine , biosimilar , apheresis , adverse effect , pharmacovigilance , immunogenicity , hematopoietic stem cell transplantation , transplantation , granulocyte colony stimulating factor , surgery , immunology , chemotherapy , platelet , immune system
The use of filgrastim biosimilars for healthy adult and pediatric donor mobilization in hematopoietic stem cell transplantation has been met with increased safety and efficacy concerns in contrast to generic small molecule drugs. In Mexico, several filgrastim‐intended copies (FIC) have been available and marketed since 2001, while no clinical comparability studies to evaluate their use in this setting have been published and thus are not considered to be true biosimilars. In this study, we report our experience using three different FIC products currently available (Filatil, Dextrifyl, and Biofilgran). Methods We retrospectively evaluated 118 related donors of all ages who received any brand 5 μg/kg subcutaneously twice daily for 4 days and were harvested in a single apheresis system on day 5. Results Donors had a median age of 38 years (range, 1‐69). A successful harvest defined as ≥2 × 10 6 CD34+ cells/kg of recipient weight was achieved in 95.8% of cases, with a median CD34+ cell dose of 9.4 × 10 6 /kg (range 1‐42.8). A single apheresis session was performed in 89.8% of cases. No significant difference in cell yield between each brand was observed. All pediatric donors had a successful harvest with similar results to adult donors. No immediate severe adverse effects were documented in any case. Conclusions In conclusion, three FICs available in Mexico were efficacious and without immediate severe adverse effects, resulting in significant cost savings. Evaluation of immunogenicity and establishment of a pharmacovigilance program with the use of FICs is warranted.