Abstract
Recently, biosimilar erythropoietin stimulating agents become available in Kazakhstan. Important properties of the biosimilar such as dose equivalency to the original medicine (originator) and the ability to maintain hemoglobin target levels remain insufficiently described in many clinical settings. Thus, the current study aims to determine dose equivalency and hemoglobin target levels in a cohort of dialysis patients who were switched from the originator to biosimilar. Retrospective data of 74 patients from different dialysis centers who received at least 6 months of originator and switched to biosimilar and had at least 6 months follow‐up were analyzed. The clinical data of 32 male and 42 female patients were collected. The mean age was 52.5 ± 13.5 years. There is no significant difference in mean levels of hemoglobin during pre‐switching from originator to biosimilar (6 months prior) and post switching period (9 months after). Additionally, a subgroup analysis of 59 patients who received originator (epoetin beta), 6 months before the switch, showed similar level of hemoglobin (110.7 ± 14 vs 113.2 ± 10 g/L, P = .05) 6 months after the switch to biosimilar (epoetin zeta) at the equivalent dose regimen (69.5 ± 29 vs 68.1 ± 30 IU/kg/wk, P = .55). However, after 9 months of switching, patients using lower doses of biosimilar (69.5 ± 29 vs 63.3 ± 30 IU/kg/wk, P < .01), showed significantly higher levels of hemoglobin (110.7 ± 14 vs 114.7 ± 8 g/L, P = .01) compared to preswitching period. In conclusion, long‐term use of lower doses of biosimilar managed to maintain hemoglobin within the target levels.
Highlights
IntroductionBlood cells and is used in the treatment of anemia caused by renal disease.[3] recombinants erythropoietin stimulating agents (rESA) treatments were shown to raise hemoglobin and hematocrit levels in patients with end stage renal disease on hemodialysis.[3]
The mean ESA dose expressed in IU/kg/wk and the mean of HB level expressed in g/L were calculated to compare the data, obtained 6 months prior to switching and 6 months after switching from originator to biosimilar
This is the first study from Kazakhstan that intended at evaluating the impact of switching from recombinants erythropoietin stimulating agents (rESA) to biosimilar ESA (bESA) on patients with renal anemia from the real clinical setting using hard clinical outcomes
Summary
Blood cells and is used in the treatment of anemia caused by renal disease.[3] rESA treatments were shown to raise hemoglobin and hematocrit levels in patients with end stage renal disease on hemodialysis.[3]. Despite their proven efficacy and crucial role in the treatment of renal anemia, the high cost of rESA agents is a contributing factor to the increasing cost of treatment, makes them inaccessible to many patients. The lower costs of biosimilars will respite some of the financial pressure on healthcare budgets and allow greater access for patients This would provide major advantages for patients and communities such as that financial resources may be more efficiently allocated to other important uses, which makes more innovative therapies available to patients.[5]. In addition to being a cost saving phenomenon, switching to biosimlars is something to be considered as a medical issue, if it could occur with other medicines as well.[6]
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