Biocomparable has comparable safety and efficacy to originator erythropoietin in haemodialysis patients

Biosimilares/Investigación | Posted 16/01/2015 post-comment0 Post your comment

A study of the treatment of patients with chronic kidney disease undergoing haemodialysis with ‘biocomparable’ and originator erythropoietin in Mexico has shown comparable efficacy and safety in terms of changes in haemoglobin levels [1].

Haemodialysis V15a16 1

This open randomized, parallel, prospective, comparative study enrolled 70 patients in Mexico aged 18−70 years with chronic kidney disease undergoing haemodialysis. Eligible subjects were randomized and received either biocomparable erythropoietin [Exetin (epoetin alfa), Laboratorios PiSA, Mexico] or originator erythropoietin [Recormon (epoetin beta), Roche, Switzerland] three times a week for 24 weeks by intravenous injection (100 IU/kg body weight).

During the period of assessment haemoglobin levels were similar in the two groups and maintained within the target range of 10−12 g/dL, in line with international recommendations. Over 90% of haemoglobin and 90% of haematocrit measurements were above the predefined lower limits of 10 g/dL and 30%, respectively in both groups.

The results showed there was no significant difference between the two preparations in terms of haemoglobin and haematocrit levels achieved. The weekly doses of both erythropoietins required to maintain haemoglobin levels were the same in both groups. The frequency of adverse events was also similar in the two treatment groups.

Based on the results the authors concluded that the biocomparable was ‘safe in clinical practice’, as well as being effective and stable in the three times a week administration regime. They added that ‘biosimilars offer a welcome opportunity to reduce treatment costs of renal anaemia’.

Conflict of interest
The authors of the research paper [1] reported that the study was funded by Laboratorios PiSA.

Editor’s comment
It should be noted that biocomparables approved in Mexico might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Biocomparables should not be confused with ‘similares’ in Mexico, which are described as ‘copies of small molecule generics that have not undergone bioequivalence testing’.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal platform – please send us your submission here.

Related articles
Biosimilar epoetin shows good safety profile in post-authorization study

Regulation of similar biotherapeutic products in Latin America

Mexican biocomparables guidelines come into force

Mexican guidelines for biocomparables 

Reference
1.   del Carmen Popoca-Martínez M, et al. Comparison of the therapeutic effects of two recombinant erythropoietin beta, biosimilar and reference formulations in patients with chronic kidney disease under hemodialysis. Clin Med Res. 2014;3(5):136-41.

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 © 2015 Pro PharmaCommunications 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