Biophysical Comparability of the Same Protein From Different Manufacturers: A Case Study Using Epoetin Alfa From Epogen® and Eprex®

Comparison of the Pharmacokinetic and Pharmacodynamic Profiles of One US-Marketed and Two European-Marketed Epoetin Alfas

“…For instance, subtle structural differences in protein conformations can be detected between Epogen Ò and Eprex Ò by means of biophysical analyses, [13] but these do not translate into clinically relevant differences. The regulatory point [8,14,15] The efficacy and safety of HX575 in the treatment of patients with chronic kidney disease was assessed in comparison with Erypo Ò / Eprex Ò , [16] and further safety data were provided in a comparative study in patients experiencing chemotherapy-induced anemia.…”

Developmental and Reproductive Toxicology

“…Amgen had licensed the active chemical in Epogen, erythropoietin, to J&J, which manufactured and marketed the drug in Europe. Although Epogen and Eprex is the same molecule, some variation in the way Eprex was manufactured (Deechongkit et al, 2006) or packaged caused patients who took the drug to develop antibodies against it (Locatelli et al, 2004). No-one could tell ahead of time that this could be the case, because J&J did not have to run clinical studies.…”

Biosimilar epoetins and other “follow‐on” biologics: Update on the European experiences

“…Epoetin alfa is more homogenous and possesses less basic isoforms than epoetin beta [80,81]. Reportedly, structural differences even exist between the established epoetin alfa formulations, Epogen 1 (Amgen) and Eprex 1 (J&J) [82]. However, this finding has been questioned, since the Eprex 1 bulk substance was isolated from a formulated product considered inappropriate for comparative studies [83].…”