Similar biological medicinal products containing recombinant erythropoietins - Scientific guideline

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

Document history


How useful was this page?

Add your rating
2 ratings
1 rating