Latest research on Epoetin

Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Latest findings

A recent population-based study analyzing the patterns of Epoetin use in a large cohort of Italian outpatients found a high degree of heterogeneity of Epoetin use across different Italian regions ranging from 1.5 per 1000 inhabitants in the Veneto region to more than 3.0 per 1000 inhabitants in the Sicily region in 2013 [9]. [source, 2016]
An analysis by Więcek et al. [3] evaluated the impact of switching from Epoetin alfa to Epoetin zeta, or vice versa, in patients with chronic kidney disease. [source, 2016]
The study showed that treatment with Epoetin alfa or Epoetin zeta could be exchanged without any clinically relevant effects (in terms of efficacy, safety, or dosing) [3]. [source, 2016]
Although a direct comparison is prevented by the reasons mentioned above, findings of the CAR and the ECAS reported a higher use of ESAs in Germany and Europe in 2001–2005 (CAR: planned ESA treatment rate of almost 40%; ECAS: approximately 45% of the patients were treated with Epoetin, either alone or in combination with iron and/or transfusion) [2, 3]. [source, 2016]
For example, with Retacrit® (Epoetin zeta; SB309), an EU-approved biosimilar of Eprex®/Erypo® (Epoetin alfa), the extent of glycoforms without an O-linked glycan chain was found to be higher in the biosimilar than in the Epoetin alfa reference product [8]. [source, 2015]
Independent studies, as well as our internal analysis (Table 2) performed after Retacrit® (Epoetin zeta) was approved in the EU, have revealed additional structural differences, including higher levels of lactosamine repeats and lower levels of sialylation relative to Eprex® (Epoetin alfa) [9]. [source, 2015]
Another EU-approved biosimilar of Eprex®/Erypo® (Epoetin alfa), Binocrit® (Epoetin alfa; HX-575), contains higher levels of phosphorylated high mannose glycans (mannose-6-phosphate glycans) at one glycosylation site, Asn-24, and lower levels of sialic acid (N-glycolylneuraminic acid and diacetylated neuraminic acid) than the reference product [10]. [source, 2015]
Independent studies, as well as our internal analysis (Table 2), performed since Binocrit® was approved, have revealed additional structural differences, including higher levels of Lewis-X structures relative to Eprex® (Epoetin alfa) [9]. [source, 2015]
No differences in bioactivity between Eprex® (Epoetin alfa) and Binocrit® (Epoetin alfa) were noted in their respective development studies [10]. [source, 2015]
An independently developed Epoetin biosimilar product licensed to Japan Chemical Research Pharmaceuticals Co., Ltd. [source, 2015]