Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis

Abstract

AimsThe appropriate use of intravenous (IV) iron is essential to minimise the requirements for erythropoiesis-stimulating agents (ESAs). The clinical efficacy of generic IV iron compared to the original formulation is controversial. We evaluated the changes that were induced after switching from a generic IV iron to an original formulation in a stable, prevalent haemodialysis (HD) population.MethodsA total of 342 patients were included, and the follow-up period was 56 weeks for each formulation. Anaemia parameters and doses of ESA and IV iron were prospectively recorded before and after the switch from generic to original IV iron.ResultsTo maintain the same haemoglobin (Hb) levels after switching from the generic to the original formulation, the requirements for IV iron doses were reduced by 34.3% (from 52.8±33.9 to 34.7±31.8mg/week, p<0.001), and the ESA doses were also decreased by 12.5% (from 30.6±23.6 to 27±21μg/week, p<0.001). The erythropoietin resistance index declined from 8.4±7.7 to 7.4±6.7 IU/kg/week/g/dl after the switch from the generic to the original drug (p = 0.001). After the switch, the transferrin saturation ratio (TSAT) and serum ferritin levels rose by 6.8%(p<0.001) and 12.4%(p = 0.001), respectively. The mortality rate was similar for both periods.ConclusionsThe iron and ESA requirements are lower with the original IV iron compared to the generic drug. In addition, the uses of the original formulation results in higher ferritin and TSAT levels despite the lower dose of IV iron. Further studies are necessary to analyse the adverse effects of higher IV iron dosages.

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“…Though the hemoglobin levels were stable in the study patients, the mean dose of IV iron sucrose per patient necessary to achieve appropriate levels decreased by 34.3% after switching from the complex generic iron sucrose to the original iron sucrose product (14). The mean dose of ESA decreased by 12.5% per patient over the same period after the switch to the original iron sucrose drug product (14).…”

“…These findings regarding marked differences in efficacy between an original iron sucrose formulation and an approved ISS have been affirmed by a prospective and multicenter study in a much larger cohort (14). There, anemia parameters, and doses of erythropoietin stimulating agents (ESAs) and of iron sucrose, were prospectively recorded before and after the switch in 342 patients with a follow-up period of 56 weeks (14).…”

“…There, anemia parameters, and doses of erythropoietin stimulating agents (ESAs) and of iron sucrose, were prospectively recorded before and after the switch in 342 patients with a follow-up period of 56 weeks (14). Though the hemoglobin levels were stable in the study patients, the mean dose of IV iron sucrose per patient necessary to achieve appropriate levels decreased by 34.3% after switching from the complex generic iron sucrose to the original iron sucrose product (14). The mean dose of ESA decreased by 12.5% per patient over the same period after the switch to the original iron sucrose drug product (14).…”

The Complete Study of the Switch from Iron-Sucrose Originator to Iron- Sucrose Similar and Vice Versa in Hemodialysis Patients

“…Side effects in patient populations have also been observed with other ISS in gastroenterology [21], gynecology [23], and recently partly in nephrology with the changes induced after switching from a generic formulation to an original formulation [42]. Our recommendation is that the selection of a specific iron should not be based solely on financial considerations, between original molecules and their similar, assuming comparable efficacy and safety, because original and similar formulations might not be interchangeable.…”

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“…Over time, the outcome of clinical studies from independent sources published in reputable journals became available [2][3][4]. They clearly showed differences in clinical performance between the innovator and follow-on products.…”