In 1989, the first recombinant erythropoietin (rEPO) preparation, epoetin-α, was approved by the US Food and Drug Administration for the treatment of anaemia associated with kidney disease. Since then, several clinically approved rEPO preparations, such as epoetin-β, epoetin-δ and the epoetin-α derivative, darbepoietin-α, have been commercially produced. Since the expiration of patent protection, a number of biosimilars have also been approved on the world market.
In 2010, epoetin-κ, which is a biosimilar of epoetin-α, was clinically approved in Japan. A study of how this biosimilar compares to epoetin-β in patients with anaemia associated with chronic kidney disease carried out in Japan showed the ‘clinical equivalence and efficacy of epoetin-κ’ [1].
The retrospective study enrolled 30 patients on dialysis, with an epoetin dosing frequency of once or twice a week, at the Kan‑Etsu Hospital (Tsurugashima, Japan). Monthly blood samples were obtained from the patients in the three months prior to and following the changeover from epoetin-β to epoetin-κ, for six months in total.
The results showed that three months following the switch to epoetin-κ, the degree of instability in anaemia parameters (red blood cell counts, haemoglobin and haematocrit) had decreased. The haemoglobin levels remained at ~11 g/dL, while the haematocrit remained at ~35% and the red blood cell counts appeared to converge at 350 x 104/μL.
Although the authors admitted that the situation prior to the change from epoetin-β to epoetin-κ requires further investigation, they concluded that ‘the results obtained in this study are indicative of the clinical equivalence and efficacy of biosimilar epoetin-κ’.
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Reference
1. Ohta S, Yasuno N, Inomoto Y, Matsuda K, Nakagawa Y, Sasagawa I, Tanaka M. Efficacy of once or twice weekly administration of epoetin κ in patients receiving hemodialysis: a retrospective study. Exp Ther Med. 2014;7(1):27-30.
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