Biosimilar epoetin-κ equivalent to epoetin-β

Biosimilares/Investigación | Posted 07/03/2014 post-comment0 Post your comment

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.

Substitution V13F14

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’.

Editor’s comment

Readers interested to learn more about anaemia control in haemodialysis patients are invited to visit www.gabi-journal.net to view the following manuscript to be published in GaBI Journal:

Disrupted anaemia control in haemodialysis patients following the switch to an Iron Sucrose Similar (ISS) after Long-Term treatment with the Originator Iron Sucrose (IS) 

If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here.

Related articles

Biosimilars approved in Japan

Biosimilar epoetins: how similar are they?

Approval of biosimilar epoetins: how similar are they?

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.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010