The quality of therapeutic EPO products, including two biosimilars, was compared with respect to content, aggregation, isoform profile and potency.

Two originator products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) and Retacrit (epoetin zeta), were compared using high performance size exclusion chromatography, ELISA, SDS-PAGE, capillary zone electrophoresis and in-vivo potency.

The results showed that the tested EPO products differed in content, isoform composition, and potency. However, of the tested products, the biosimilars had the same or even better quality compared to the originals. Especially, the potency of originals was found may significantly differ from the value on the label.

The differences between the EPO products shown by this research further highlight the difficulties with demonstrating the ‘comparability’ of biosimilar products and the fact that the manufacturing process is critical in producing biosimilars. However, in this case maybe ‘biobetter’ is indeed the correct term.

Despite the challenges, EPO biosimilars have obviously got it right, providing, not only cost savings and greater accessibility to biopharmaceuticals, but also high quality products.

Related articles

Biosimilar epoetins: how similar are they?

The biosimilars challenge

Reference

Brinks V, et al. Quality of original and biosimilar epoetin products. Pharm Res. Published online: 01 October 2010. Doi: 10.1007/s11095-010-0288-2