References
- Levin A. Identification of patients and risk factors in chronic kidney disease – evaluating risk factors and therapeutic strategies. Nephrol Dial Transplant 2001;16(Suppl 7):57–60
- Barbone FP, Johnson DL, Farrell FX, et al. New epoetin molecules and novel therapeutic approaches. Nephrol Dial Transplant 1999;14(Suppl 2):80–4
- Downey P. Recombinant human erythropoietin as a treatment for anemia of prematurity. J Perinat Neonatal Nurs 1997;11:57–68
- Jelkmann W. Molecular biology of erythropoietin. Intern Med 2004;43:649–59
- Locatelli F, Aljama P, Barany P, et al. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004;19\(Suppl 2):ii1–47
- Canadian Erythropoietin Study Group. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis. BMJ 1990;300:573–8
- European Generic Medicines Agency. Frequently asked questions about biosimilar medicines. Available from http://www.egagenerics. com/FAQ-biosimilars.htm [Last accessed 2 Jan 2008]
- Macdougall IC. Recent advances in erythropoietic agents in renal anemia. Semin Nephrol 2006;26:313–8
- Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm 2004;3:43–7
- European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. CHMP/437/04. EMEA 2005. Available from http://www.emea.europa.eu/pdfs/human/ biosimilar/043704en.pdf [Last accessed 30 Nov 2007]
- European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues: guidance on similar medicinal products containing recombinant erythropoietins. CHMP/94526/05. EMEA 2006. Available from http://www.emea.europa.eu/pdfs/human/ biosimilar/9452605en.pdf [Last accessed 21 Dec 2007]
- 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 [published erratum in Curr Med Res Opin 2008;24(4):1155]. Curr Med Res Opin 2008;24:625–37
- Casadevall N, Dupuy E, Molho-Sabatier P, et al. Autoantibodies against erythropoietin in a patient with pure red-cell aplasia. N Engl J Med 1996;334:630–3
- Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346:469–75
- Eschbach JW, Egrie JC, Downing MR, et al. Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med 1987;316:73–8
- European Directorate for the Quality of Medicines and Healthcare (EDQM). The European Pharmacopoeia. 6th edn. Strasbourg: EDQM, 2007