La erythropoietin, also known as EPO, is a hormone produced by our kidneys, whose essential activity is to promote the increase in red blood cells. At the end of the XNUMXth century, the first replica of the natural hormone produced through biotechnology, recombinant human erythropoietin (EPO or epoetin), was released.
It is a medication administered to patients with anemia caused by kidney failure. Kidney disease-related anemia is therefore treated with a recombinant EPO supplementation strategy. In addition, it is used as standard treatment in patients requiring dialysis.
Keep in mind that the anemia It also represents a frequent complication both in patients with hematological malignancies and with solid tumors, such that recombinant human erythropoietin has been shown to stimulate erythropoiesis in patients with anemia induced by chemotherapy and radiotherapy, thus reducing transfusion requirements and improving fatigue and blood pressure. fatigue.
They are currently marketed in Europe. five biosimilar medicines with different versions of EPO as active principle. The first to be authorized in Europe were Binocrit, Abseamed and EPO alfa Hexal, in August 2007 and are biosimilars to the original EPO alfa Eprex/Erypo. Retacrit and Silapo (approved in December 2007) are also biosimilars of the same original EPO alfa although they chose to call their active ingredient EPO zeta.
In any case, the approval by the EMA certifies that the equivalence of the biosimilars with the original product has been demonstrated with very guaranteeing criteria for patients. As often occurs between batches of the original product itself, slight structural variations have a significant clinical impact on the efficacy and safety of these products.
Furthermore, the biosimilar erythropoietins have demonstrated equivalence in multiple clinical trials with the reference medicines. This, together with the strict requirements of the EMA for its authorization, provides all the guarantees regarding the safety, efficacy and quality of these products.
Likewise, it must not be forgotten that these medicines produce a benefit in the sustainable treatment of patients thanks to the notable reduction in the price of EPOs that their entry into the market has entailed. For example, the introduction of the biosimilar EPO led to cumulative savings of 551 million euros in Germany since 2007, according to data from the pharmaceutical Sandoz.