Importance of erythropoietin in the treatment of anemia

The world market for erythropoietin (Epo) accounts for several billion dollars a year. Due to the expiring term of protection of intellectual property rights or regional limitations of patent protection researchers and pharmaceutical companies are stimulated to design generic or so called modified Epo preparations. The aim of the review was to screen Epo preparations currently available on the market and search for new concepts developed in order to replace existing recombinant Epo protein preparations with active polypeptides or gene therapy strategies. Strategies of using Epo properties other than erythropoietic ones for therapeutic purposes are also extremely interesting.
Over fifteen years of experience of anemia treatment with recombinant human Epo a (rHuEpo α) allowed us to understand pharmacokinetics, pharmacoeconomics and clinical benefits of this drug. Nephrologists, hematologists and oncologists have developed standard procedures for clinical application in various diseases of rHuEpo a, a cytokine/hormone manufactured using recombinant DNA technology whose structure is very close to natural endogenous Epo. Millions of doses administered to patients allowed safe and patient-friendly treatment procedures to be developed.
New Epo preparations recently placed on the market, biogenerics or so called NESP have a long way to achieve therapeutic and economic success. Biogenerics need manufacture standardization and clinical studies apart from known therapeutic properties of Epo. Darbepoetin a in turn requires more extensive clinical studies (most of the studies lasted 12 weeks, the recent ones lasted a little longer) engaging larger patient cohorts in order to understand the ”biology” of this preparation better and compare it with rHu Epo a in well designed studies. Moreover, costs of darbepoetin a treatment, despite a different schedule of administration, are so far higher than costs of rHuEpo a treatment.