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’.

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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.

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