Use of biosimilars in hematopoietic stem cells transplantation

The entry of biosimilars into the market raised specific issues pertinent to their use in clinical practice in the settings of hematopoietic stem cells transplantation (HSCT); this procedure is by itself characterized by high cost and therefore there is a particular interest in mechanisms and procedures allowing to save costs. On the other hand HSCT procedure is currently monitored by complex mechanisms that involve scientific accreditation and surveillance operated by regulatory authorities. This specific Review is dedicated to their use in HSCT. As regard G-CSF the use in HSCT is related to three main indications: Stem cell mobilization and collection from healthy donors for use in allografting; Stem cell mobilization and collection from patients undergoing autologous stem cell transplantation; Prevention and treatment of neutropenic fever in transplanted patients. As regard Erythropoietin (Epo) has been used with the aim to accelerate the recovery of red blood cells following HSCT. The literature on the field is reviewed. The availability of biosimilars is an important challenge to reduce the cost of the global procedure of HSCT. The caution manifested by physicians is essentially related to the extrapolation approach and to the absence of published experiences in the field. The first experiences reported recently in mobilization procedures with G-CSF and in hematopoietic recovery after autologous transplants suggest safety and efficacy of biosimilars in these indications. On the contrary, no evidence definitely supports safety and efficacy of GCSF biosimilars for HPC mobilization in healthy donors.