Several clinically approved recombinant erythropoietin (rEPO) preparations, such as epoetin-β, epoetin-δ and the epoetin-α derivative, darbepoetin-α, have been commercially produced. Since the expiration of patent protection, a number of novel rEPO biosimilars have been approved on the world market. In 2010, epoetin-κ, which is biosimilar to epoetin-α, was clinically approved. Epoetin-κ is a biopharmaceutical product that is based on serum-free media following master cell bank preparation. The present study analyzes the results obtained during a six-month observation period, in which the administration of epoetin-β was switched to that of epoetin-κ. In a cohort of patients receiving chronic dialysis, who were clinically in a state of relative calm and were in control of their renal anemia, it was possible to sustain good control of the anemia by reducing the frequency of the epoetin-β administration from the conventional and empirically determined three times a week to twice a week, and further to once a week. Furthermore, the good control was maintained upon changing from the administration of epoetin-β to that of epoetin-κ. Moreover, three months subsequent to this switch, the degree of instability observed among the patients had decreased. Despite the fact that the situation following the changeover requires further investigation, it may be concluded that the results obtained in this study are indicative of the clinical equivalence and efficacy of epoetin-κ.
Ohta, S., Yasuno, N., Inomoto, Y., Matsuda, K., Nakagawa, Y., Sasagawa, I., & Tanaka, M. (2013). Efficacy of once or twice weekly administration of epoetin κ in patients receiving hemodialysis: A retrospective study. Experimental and Therapeutic Medicine, 7(1), 27–30. https://doi.org/10.3892/etm.2013.1384