Similar biological medicinal products containing recombinant erythropoietins

This document lays down lays down the non-clinical and clinical requirements for recombinant human erythropoietin (epoetin)-containing medicinal products claiming to be similar to another one already marketed.

Keywords: Erythropoietin, epoetin, recombinant biological medicinal products, indication, efficacy, safety, comparability, extrapolation


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