Non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha - Scientific guideline

This document lays down considerations on the non-clinical and clinical development of recombinant interferon alfa-containing medicinal products claiming to be similar to another such product already authorised.

Keywords: Recombinant interferon alpha, similar biological medicinal products, biosimilar, non-clinical studies, clinical studies