UNASSIGNED: @entity1 recombinant @entity1261 ( @entity1261 ), filgrastim ( @entity17083 ; Amgen, Thousand Oaks, CA, USA), has been widely used for the mobilization of @entity2280 (+) hematopoietic stem cells (HSC) from healthy donors. The experience with biosimilar @entity1261 agents in this area is limited. We performed a prospective study assessing Tevagrastim (biosimilar filgrastim, XMO2; Teva, Israel) for mobilization of @entity2280 (+) peripheral blood HSC in HLA-matched healthy sibling donors for transplantation in 24 @entity1 with @entity3052 ( @entity3052 ) and high-risk @entity2590 ( @entity2590 ) (NCT01542944). Results were compared to a historical control group of sibling donors who received filgrastim for stem cell mobilization for allogeneic stem cell transplantations in @entity1 with @entity3052 and @entity2590 . The healthy donors received Tevagrastim or filgrastim in a dose of 10  g/kg body weight (BW) subcutaneously for 4 days. The target yields of @entity2280 (+) cells was 5  * 10(6) @entity2280 (+) cells/kg BW of the recipient. A median 10.2  * 10(6) (range, 2.52 to 35.4) and 9.35  * 10(6) (range, 3.7 to 30.6) @entity2280 (+) cells per kg BW were collected in the Tevagrastim and filgrastim groups, respectively. All @entity1 promptly engrafted with a median day of absolute neutrophil count (ANC) of >.5  * 10(9)/L and >1  * 10(9)/L of 13 days (range, 10 to 21) and 13.5 days (range, 10 to 22), respectively in the Tevagrastim group and 12 days (range, 10 to 18) and 13 days (range, 10 to 18) in the filgrastim group, respectively. Platelets reached counts of >20  * 10(9)/L and >50  * 10(9)/L within a median of 14 days (range, 11 to 33) and 17 days (range, 12 to 33) in the Tevagrastim group and 13 (range, 10 to 29) and 15 (range, 10 to 32) days in the filgrastim group, respectively. The donors developed only mild and transient side effects, which were not different between the Tevagrastim study group and the filgrastim historical control group. Similarly, the transplantation-related @entity137  and outcomes did not differ between the @entity1 who underwent transplantation with Tevagrastim-mobilized grafts and the filgrastim historical controls. In summary, we observed a similar yield of @entity2280 (+) stem cell mobilization in the Tevagrastim study group and the filgrastim historical control group with similar engraftment kinetic, hematopoietic reconstitution, and transplantation outcome. Tevagrastim administration was safe with minimal side effects and @entity137 not different than historical controls. The lack of significant differences for all parameters of stem cell collection, engraftment, and safety with the biosimilar XMO2 Tevagrastim demonstrate the "similarity" of the biosimilar and recombinant @entity1 @entity1261 in  this indication.

Biosimilar Filgrastim (Tevagrastim, XMO2) for Allogeneic  Hematopoietic Stem Cell Mobilization and  Transplantation in XXXX with @entity3052 .

@entity1 :: ('9606', 'Species') :: ['human', 'patients', 'Human'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity1261 :: ('1440', 'Gene') :: ['G-CSF', 'granulocyte colony-stimulating factor'] @entity17083 :: ('MESH:C554038', 'Chemical') :: ['Neupogen'] @entity2590 :: ('MESH:D009190', 'Disease') :: ['myelodysplastic syndromes', 'MDS'] @entity3052 :: ('MESH:D015470', 'Disease') :: ['acute myelogenous leukemia', 'AML'] @entity2280 :: ('947', 'Gene') :: ['CD34']
@entity1 :: (9606,Species) :: ['Patients']
