Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)

Keywords Granulocyte-colony stimulating factor (G-CSF), recombinant, similar biological medicinal products, comparability, non-clinical studies, clinical studies
Description This document is an annex to the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. It provides guidance for demonstration of comparability of two recombinant granulocyte colonystimulating factor-containing medicinal products.

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