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

INTRODUCTION: Recombinant human erythropoietin (rhEPO, epoetin) has prospered in the treatment of renal and chemotherapy-associated anemias. Since the patents of the original epoetins expired, biosimilars have been launched. Because these are not fully identical to the original products, non-clinical and clinical studies are necessary to show similarity with respect to quality, safety, and efficacy.

AREAS COVERED: The article summarizes experiences with EU-approved biosimilar epoetins. In particular, the issue of immunogenicity is considered. Neutralizing anti-EPO antibodies can cause pure red cell aplasia (PRCA). Further, a first view is offered on future erythropoiesis-stimulating therapies.

EXPERT OPINION: The term "biosimilar" should only be used for follow-on biopharmaceuticals approved under a defined regulatory pathway. The primary rationale for the therapy with biosimilars is cost saving. Two biosimilar epoetins are available in the EU that are used at the same dose(s) and dosing regimen(s) for indications of the reference product. Their advent has stimulated innovator companies to develop second-generation products with improved pharmacokinetic properties. EPO-mimicking peptides are a new therapeutic option. Other strategies focus on orally active chemical drugs that induce endogenous EPO production ("HIF stabilizers"). Epo gene transfer is also possible, but needs to be further explored with respect to efficacy and safety.