Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: A parallel, randomized, double blind study

Pérez-Oliva, Jorge F.; Casanova-González, Martha; García-García, Idrian; Porrero-Martín, Pedro J; Valenzuela-Silva, Carmen; Hernández-Montero, Tairí; Lagarde-Ampudia, Marcia; Casanova-Kutsareva, Yuri; Ávila-Albuerne, Yisel; Vargas-Batista, Alicia; Bobillo-López, Hailen; Herrera-Valdés, Raúl; López-Saura, Pedro

doi:10.1186/1471-2369-6-5

Cited by 21 publications

(15 citation statements)

References 37 publications

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“…Overall, about 80 different rhEPOs are marketed globally [75]. Clinical trials have shown equivalence of copied rhEPOs from Cuba [76], China [77] and Korea [78], when compared with original epoetin alfa. Still, copied products may not always meet the common quality standards.…”

Section: Copied Products From Other Parts Of the Worldmentioning

confidence: 98%

Biosimilar recombinant human erythropoietins ("epoetins") and future erythropoiesis-stimulating treatments

Jelkmann

2012

Expert Opinion on Biological Therapy

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Section: Copied Products From Other Parts Of the Worldmentioning

confidence: 98%

Biosimilar recombinant human erythropoietins ("epoetins") and future erythropoiesis-stimulating treatments

Jelkmann

2012

Expert Opinion on Biological Therapy

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“…In addition, outside the EU and the USA, 'copy' epoetins are already produced by companies other than the innovators and used clinically as anti-anemic drugs. For example, a CHO cell-derived recombinant human erythropoietin produced in Havana, Cuba, has been shown to have therapeutic efficacy (P erez-Oliva et al, 2005). All recombinant proteins are, however, associated with a number of issues that distinguish them from traditional drugs and their generics.…”

Section: Biosimilar Eposmentioning

confidence: 99%

Development of Recombinant Erythropoietin and Erythropoietin Analogs

Macdougall

2009

Textbook of Nephro-Endocrinology

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“…One hundred and twenty hours after injection, EPO levels had returned to basal levels. Mean life was 22.5 h; maximum concentration was 112.7 mIU/ml at a maximum time of 18.1 h [15].…”

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Erythropoietin pharmacology

et al. 2007

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Anaemia is a frequent complication in cancer patients and may be multifactorial in origin. Treatment with recombinant human erythropoietin (rHuEPO) is an alternative to red blood cell transfusion. The evidence from clinical trials has established that patients with chemotherapy-induced anaemia with a haemoglobin concentration below 10 g/dl benefit from epoetin therapy. The native glycoprotein hormone consists of 165 amino acids with three N-glycosylation and one O-glycosylation sites. Epoetin and darbepoetin bind to the EPO receptor to induce intracellular signalling by the same intracellular molecules as native EPO. There are some differences in the glycosylation pattern which lead to variations in the pharmacokinetics and pharmacodynamics profiles. Pharmacokinetic and therapeutic studies have examined the use of rHuEPO administered intravenously and subcutaneously and there is accumulating evidence that the latter route has several advantages in cancer patients. After subcutaneous administration, the bioavailability of epoetin is about 20-30% and has a plasma half-life of >24 h. Darbepoetin has a longer half-life after subcutaneous administration of 48 h. The general recommendations are based on evidence from trials in which epoetin was administered 150 U/kg thrice weekly. The recommended initial dose for darbepoetin alpha is 2.25 mug/kg per week. The most serious adverse effects are hypertension, bleeding and increased risk of thrombotic complications. Caution is advised when used in patients who are at high risk for thromboembolic events. In the management of anaemic cancer patients, physicians should closely follow the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) guidelines.

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Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: A parallel, randomized, double blind study

Cited by 21 publications

References 37 publications

Biosimilar recombinant human erythropoietins ("epoetins") and future erythropoiesis-stimulating treatments

Biosimilar recombinant human erythropoietins ("epoetins") and future erythropoiesis-stimulating treatments

Development of Recombinant Erythropoietin and Erythropoietin Analogs

Erythropoietin pharmacology

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