Jelkmann W. Molecular biology of erythropoietin. Intern Med. 2004;43:649–59.PubMed
Deicher R, Hörl WH. Differentiating factors between erythropoiesis-stimulating agents: a guide to selection for anaemia of chronic kidney disease. Drugs. 2004;64:499–509.PubMed
Locatelli F, Covic A, Eckardt KU, et al. Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant. 2009;24:348–54.PubMed
Spinowitz B, Germain M, Benz R, et al. A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2008;3:935–7.
Piccolo AM, Malagoli A, Komninos G, et al. Subcutaneous epoetin-alpha every one, two, and three weeks in renal anemia. J Nephrol. 2002;15:565–74.
Provenzano R, Bhaduri S, Singh AK, et al. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease. The PROMPT study. Clin Nephrol. 2005;64:113–23.PubMed
Lim VS, Kirchner PT, Fangman J, et al. The safety and the efficacy of maintenance therapy of recombinant human erythropoietin in patients with renal insufficiency. Am J Kidney Dis. 1989;14:496–506.PubMed
Provenzano R, Garcia-Mayol L, Suchinda P, et al. Once-weekly epoetin alfa for treating the anemia of chronic kidney disease. Clin Nephrol. 2004;61:392–405.PubMed
Benz R, Schmidt R, Kelly K, et al. Epoetin alfa once every 2 weeks is effective for initiation of treatment of anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2007;2:215–21.PubMed
Germain M, Ram CV, Bhaduri S, et al. Extended epoetin alfa dosing in chronic kidney disease patients: a retrospective review. Nephrol Dial Transplant. 2005;20:2146–52.PubMed
Pergola P, Gartenberg G, Fu M, et al. A randomized controlled study of weekly and every-2-week dosing of epoetin alfa in CKD patients with anemia. Clin J Am Soc Nephrol. 2009;4:1731–40.PubMed
Pergola PE, Gartenberg G, Fu M, et al. A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia. Clin J Am Soc Nephrol. 2010;5:598–606.PubMed
Gobin J, Cernii A. Mc Lean R et al. Conversion from epoetin alfa to darbepoetin alfa for management of anemia in a community chronic kidney disease centre: a retrospective cohort study. Clin Drug Investig. 2011;31:113–20.PubMed
Jelkmann W. Biosimilar epoetins and other “follow-on” biologics: update of the European experiences. Am J Hematol. 2010;85:771–80.PubMed
European Public Assessment Report (EPAR). Eporatio®
[online]. Available from URL: http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001033/human_med_001204.jsp
[Accessed 2012 Nov 26].
Gertz B, Kes P, Essaian A, et al. Epoetin alfa: efficacy and safety of subcutaneous administration in anemic pre-dialysis patients in the maintenance phase in comparison to epoetin beta. Curr Med Res Opin. 2012;28:1101–10.PubMed
Sörgel F, Thyroff-Frieslinger U, Vetter A, et al. Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial. BMC Clin Pharmacol. 2009;9:10.PubMed
Sörgel F, Thyroff-Friesinger U, Vetter A, et al. Biosimilarity of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration. Int J Clin Pharmacol. 2009;47:391–401.
Haag-Weber M, Vetter A, Thyroff-Friesinger U, et al. Therapeutic equivalence, long-term and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009;72:380–90.PubMed
Hörl WH, Locatelli F, Haag-Weber M, et al. Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10–12 g/dl. Clin Nephrol. 2012;78:24–32.PubMed
Haag-Weber M, Eckardt K-U, Hörl WH, et al. Safety, immunogenicity of subcutaneous biosimilar epoetin alfa (HX575) in non-dialysis patients with renal anaemia: a multi-centre, randomised, double-blind study. Clin Nephrol. 2012;77:8–17.PubMed
Lissy M, Ode M, Roth K. Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study. Drugs. 2011;11:61–75.
Macdougall IC, Roger S, De Francisco A, et al. Antibody-mediated pure red cell aplasia in patients receiving ESA therapy: new insights. Kidney Int. 2012;81:727–32.PubMed
Seidl A, Hainzl O, Richter M, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packing as a cause of immunogenicity. Pharm Res. 2012;29:1454–67.PubMed
Van Beers MM, Jiskoot W, Schellekens H. On the role of aggravates in the immunogenicity of recombinant human interferon beta in patients with multiple sclerosis. J Interferon Cytokine Res. 2010;30:767–75.PubMed
Schellekens H, Jiskoot W. Erythropoietin-associated PRCA: still an unsolved mystery. J Immunotoxicol. 2006;3:123–30.PubMed
Ryan MH, Heavner GA, Brigham-Burke M, et al. An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin. Int Immunpharmacol. 2006;6:647–55.
Jiang Y, Nashed-Samuel Y, Li C, et al. Tungsten-induced protein aggregation: solution behaviour. J Pharm Sci. 2009;98:4765–70.
Bee JS, Nelson SA, Freund E, et al. Precipitation of a monoclonal antibody to soluble tungsten. J Pharm Sci. 2009;98:3290–301.PubMed
Liu W, Swift R, Torraca G, et al. Root cause analysis of tungsten-induced protein aggregation in pure-filled syringes. PDA J Pharm Sci Tech. 2010;64:11–9.
Wizemann V, Rutkowski B, Baldamus C, et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008;24:625–37.PubMed
Krivoshiev S, Todorov VV, Manitius J, et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin. 2008;24:1407–15.PubMed
Krivoshiev S, Wizemann V, Czekalski S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther. 2010;27:105–17.PubMed
Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology: a single-dialysis center experience. Clin Nephrol. 2011;75:59–62.PubMed
Brinks V, Hawe A, Basmeleh AH, et al. Quality of original and biosimilar epoetin products. Pharm Res. 2011;28:386–9.PubMed
Hörbrand F, Bramlage P, Fischaleck J, et al. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol. Epub 2012 Oct 2.
Abraham I, MacDonald K. Clinical safety of biosimilar recombinant human erythropoietins. Expert Opin Drug Saf. 2012;11:819–40.PubMed
Goldsmith D. 2009: a requiem for rHuEPOs: but should we nail down the coffin in 2010? Clin J Am Soc Nephrol. 2010;5:929–35.
Keithi-Reddy SR, Kandasamy S, Singh AK. Pure red cell aplasia due to follow-on epoetin. Kidney Int. 2008;74:1617–22.PubMed
Schellekens H. The first biosimilar epoetin: but how similar is it? Clin J Am Soc Nephrol. 2008;3:174–8.PubMed
Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy. 2005;25:954–62.PubMed
Praditpornsilpa K, Tiranathanagul K, Kupawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int. 2011;80:88–92.PubMed
Macdougall IC, Ashenden M. Current and upcoming erythropoiesis-stimulating agents, iron products, and other novel anemia medications. Adv Chronic Kidney Dis. 2009;16:117–30.PubMed
Perez-Oliva JF, Casanova-Gonzales M, Garcia-Garcia I, et al. Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: a parallel randomized, double blind study. BMC Nephrol. 2005;6:1–11.
Bock HA, Hirt-Minkowski P, Brunisholz M, et al. Darbepoetin alpha in lower-than-equimolar dosis maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta. Nephrol Dial Transplant. 2008;23:301–8.PubMed
Tanakitcharu P, Siriwiwatanakul N. Hemoglobin response and influence on left ventricular hypertrophy after 24-week treatment of a biosimilar epoetin-alfa in hemodialysis patients with anemia. J Med Assoc Thai. 2007;90:2574–86.
Metivier F, Marchais SJ, Guerin AP, et al. Pathophysiology of anaemia: focus on the heart and blood vessels. Nephrol Dial Transplant. 2000;15(Suppl. 3):14–8.PubMed
Park SS, Park J, Ko J, et al. Biochemical assessment of erythropoietin products from Asia versus US epoetin alfa manufactured by Amgen. J Pharm Sci. 2008;98:1688–99.
Schmidt CA, Ramos AS, da Silva JEP, et al. Availiaco da atividade e caracterizacão de erithropoietin a humana recombinante em produtos farmacéuticos. Arq Bras Endocrinol Metabol. 2003;47:183–9.
Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm. 2004;3:43–7.
Wish JB. Erythropoiesis-stimulating agents and pure red-cell aplasia: you can’t fool mother nature. Kidney Int. 2011;80:11–3.PubMed
Schellekens H. Follow-on biologics challenges of the next generation. Nephrol Dial Transplant 2005; 20 Suppl. 4: iv31–6.
Roger SD, Goldsmith D. Biosimilars: it’s not as simple as cost alone. J Clin Pharm Ther. 2008;33:459–64.PubMed
Roger SD. Biosimilars: current status and future directions. Expert Opin Biol Ther. 2010;10:1–8.
Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001;84(Suppl. 1):3–10.PubMed
Macdougall IC, Gray SJ, Elston O, et al. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol. 1999;10:2392–5.PubMed
Doshi S, Chow A, Pérez Ruixo JJ. Exposure-response modelling of darbepoetin alfa in anemic patiens with chronic kidney disease not receiving dialysis. J Clin Pharmacol. 2010;50:755–905.
Aarup M, Bryndum J, Dieperink H, et al. Clinical implications of converting stable haemodialysis patients from subcutaneous to intravenous administration of darbepoetin alfa. Nephrol Dial Transplant. 2006;21:1312–6.PubMed
Sharma A, Yee J, Gandra SR, et al. Estimate of maintenance EPO to darbepoetin alfa dose conversion ratio in a hospital-based dialysis patient population. Curr Med Res Opin. 2010;26:2679–87.PubMed
Horowitz J, Agarwal A, Huang F, et al. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009;15:741–50.PubMed
Locatelli F, Canaud B, Giacardy F, et al. Treatment of anaemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rHuEPO). Nephrol Dial Transplant. 2003;18:362–9.PubMed
Mann J, Kessler M, Villa G, et al. Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients: a combined analysis of eight multicenter trials. Clin Nephrol. 2007;67:140–8.PubMed
Tolman C, Richardson D, Bartlett C, et al. Structured conversion from thrice weekly to weekly erythropoietic regimens using a computerized decision-support system: a randomized clinical study. J Am Soc Nephrol. 2005;16:1463–70.PubMed
Weiss LG, Clyne N, Divino FJ, et al. The efficacy of once weekly compared with two or three times weekly subcutaneous epoetin beta: results from a randomized controlled mulitcenter trial. Swedish Study Group. Nephrol Dial Transplant. 2000;15:2014–9.PubMed
Locatelli F, Baldamus CA, Villa G, et al. Once-weekly compared with three-times-weekly subcutaneous epoetin beta: results from a randomized, multicenter, therapeutic-equivalence study. Am J Kidney Dis. 2002;40:119–25.PubMed
Lafeuille MH, Bailey RH, Vekeman F, et al. Drug utilization and cost for erythropoiesis-stimulating agents in a long-term care resident population with chronic kidney disease. Consult Pharm. 2010;25:493–500.PubMed
Rottembourg JB, Bridges I, Pronai W, et al. An observational study of the effectiveness of darbepoetin alpha administered to dialysis patients once every 2 weeks for 12 months. Clin Nephrol. 2011;75:242–50.PubMed
Feriani M, De Meester JMJ, McMahon LP, et al. Extended dosing of darbepoetin alfa in peritoneal dialysis patients. BMC Nephrol. 2011;12:13.PubMed
Ling B, Walczyk M, Agarwal A, et al. Darbepoetin alfa administered once monthly maintains haemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol. 2005;63:327–54.PubMed
Galle J-C, Claes K, Kiss I, et al. An observational color study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Nephrol Dial Transplant. 2012;27:2303–11.PubMed
Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085–98.PubMed
Pfeffer MA, Burdmann EA, Chen CY, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361:2019–32.PubMed
Lim WH, Boudville N, Pellicano S, et al. Patients’ perceptions of subcutaneous delivery of darbepoetin alfa by autoinjector prefilled pen versus prefilled syringe: a randomized, crossover study. Clin Ther. 2012;34:1948–53.PubMed
Macdougall IC, Robson R, Opatrna S, et al. Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with chronic kidney disease. Clin J Am Soc Nephrol. 2006;1:1211–5.PubMed
Jarsch M, Brandt M, Lanzendörfer M, et al. Comparative erythropoietin receptor binding kinetics of C.E.R.A. and epoetin-beta determined by surface plasmon resonance and competition binding assay. Pharmacology. 2008;81:63–9.PubMed
Koch M, Henrich D, Faust J, et al. Initial use of once-monthly administration of C.E.R.A. is effective and safe in correcting renal anemia in non-dialysis patients: the MERCUR trial. Clin Nephrol. 2012;78:189–97.PubMed
Levin NW, Fishbane S, Valdés Cañedo F, et al. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007;370:1415–21.PubMed
Sulowicz W, Locatelli F, Ryckelynck JP, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol. 2007;2:637–46.PubMed
Klinger M, Arias M, Vargemezis V, et al. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007;50:989–1000.PubMed
Spinowitz B, Coyne DW, Lok CE, et al. C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks. Am J Nephrol. 2008;28:280–9.PubMed
Macdougall IC, Walker R, Provenzano R, et al. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol. 2008;3:337–47.PubMed
Roger SD, Locatelli F, Woitas RP, et al. C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrol Dial Transplant. 2011;26:3980–6.PubMed
Canaud B, Mingardi G, Braun J, et al. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008;23:3654–61.PubMed
Kessler M, Martinez-Castelao A, Siamopoulos KC, et al. C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: the ARCTOS extension study. Hemodial Int. 2010;14:233–9.PubMed
Mann JF, de Francisco A, Nassar G, et al. Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease. Clin Nephrol. 2011;76:9–15.PubMed
Heidenreich S, Leistikow F, Zinn S, et al. Monthly administration of a continuous erythropoietin receptor activator provides efficient haemoglobin control in non-dialysis patients during routine clinical practice: results from the non-interventional, single-cohort, multicentre. SUPRA study. Clin Drug Investig. 2012;32:99–110.PubMed
Leypolt JK, Loghman-Adham M, Jordan P, et al. Effect of hemodialysis and hemofiltration on plasma C.E.R.A. concentrations. Hemodial Int. 2012;16:20–30.
Carrera F, Lok CE, de Francisco A, et al. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010;25:4009–17.PubMed
Minutolo R, Zamboli P, Chiodini P, et al. Conversion of darbepoetin to low doses of CERA maintains haemoglobin levels in non-dialysis chronic kidney disease patients. Blood Purif. 2010;30:186–94.PubMed
Cano F, Alarcon C, Azocar M, et al. Continuous EPO receptor activator therapy of anemia in children under peritoneal dialysis. Pediatr Nephrol. 2011;26:1303–10.PubMed
Locatelli F, Mann JF, Aldigier JC, et al. C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney disease. Clin Nephrol. 2010;73:94–103.PubMed
Stead RB, Lambert J, Wessels D, et al. Evaluation of the safety and pharmacodynamics of Hematide, a novel erythropoietic agent, in a phase 1, double-blind, placebo-controlled, dose-escalation study in healthy volunteers. Blood. 2006;108:1830–4.PubMed
Wrighton NC, Farrell FX, Chang R, et al. Small peptides as potent mimetics of the protein hormone erythropoietin. Science. 1996;273:458–64.PubMed
Fan Q, Leuther KK, Holmes CP, et al. Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol. 2006;34:1303–11.PubMed
Macdougall IC. Recent advances in erythropoietic agents in renal anemia. Semin Nephrol. 2006;26:313–8.PubMed
Omontys® (peginesatide) injection [prescribing information]. Palo Alto (CA): Affymax Inc, 2012.
Macdougall IC, Wiecek A, Tucker B, et al. Dose-finding study of peginesatide for anemia correction in chronic kidney disease patients. Clin J Am Soc Nephrol. 2011;6:2579–86.PubMed
Besarab A, Zeig SN, Martin ER, et al. An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients. Nephrology. 2012;13:95.PubMed
Macdougall IC. New anemia therapies: translating novel strategies from bench to bedside. Am J Kidney Dis. 2012;59:444–51.PubMed
Mikhail A. Profile of peginesatide and its potential for the treatment of anemia in adults with chronic kidney disease who are on dialysis. J Blood Med. 2012;3:25–31.PubMed
Woodburn KW, Schatz PJ, Fong KL, et al. Preclinical safety and pharmacology of Hematide, a peptidic erythropoiesis stimulating agent (ESA), in rats and monkeys. Drug Chem Toxicol. 2008;31:229–44.PubMed
Woodburn KW, Fan Q, Winslow S, et al. Hematide is immunologically distinct from erythropoietin and corrects anemia induced by antierythropoietin antibodies in a rat pure red cell aplasia model. Exp Hematol. 2007;35:1201–8.PubMed
Macdougall IC, Rossert J, Casadevall N, et al. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med. 2009;361:1848–55.PubMed
Louët S. Lessons from Eprex for biogeneric firms. Nat Biotechnol. 2003;21:956–7.PubMed
Yang J. Two cases of pure red-cell aplasia due to anti-erythropoietin antibodies. J Nephrol. 2005;18:102–5.PubMed
Jacob A, Sandhu K, Nicholas J, et al. Antibody-mediated pure red cell aplasia in a dialysis patient receiving darbepoetin alfa as the sole erythropoietic agent. Nephrol Dial Transplant. 2006;21:2963–5.PubMed
Howman R, Kulkarni H. Antibody-mediated acquired pure red cell aplasia (PRCA) after treatment with darbepoetin. Nephrol Dial Transplant. 2007;22:1462–4.PubMed
Attaf DC, Torres PA. Not all new recombinant human erythropoietins are biosimilars [letter]. Kidney Int. 2009;74:441.
Unger EF, Thompson AM, Blank MJ, et al. Erythropoiesis-stimulating agents: time for a reevaluation. N Engl J Med. 2010;362:189–92.PubMed
Szczech LA. Chronic kidney disease anemia management: what should be done? Blood Purif. 2011;31:186–8.PubMed