Erythropoietin Biosimilar Products and Immunogenicity: A Pharmacovigilance Study

Abstract

The aim of the present study was to evaluate the immunogenicity of a generic product of erythropoietin registered in Jordan, by detecting the presence of anti-recombinant human erythropoietin antibodies in the serum via an ELISA technique. Materials and Methods : Briefly, polystyrene micro-titer plates (96-well) were coated with rhEPO (the generic product) at 10 g/1mL. Goat anti-human IgG:HRP or rabbit polyclonal to human IgM:HRP was added to the wells and incubated. A prepared substrate solution was then added to each well. The absorbance was measured with a microplate reader after green color development (n=3). The sera of 95 patients were tested for the presence of IgM or IgG antibodies. Results : Antibodies were detected in 26.3% of the population; where 16.8% were found to have only IgG antibodies, 7.4% had only IgM antibodies, and 2.1% had both antibodies. Cigarette smoking correlated significantly with the development of IgG antibodies. Moreover folate administration correlated inversely with decreasing the risk of developing IgM antibodies . Conclusions : this study proves the immunogenic effect for this product