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
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Reflection paper: Non-clinical and clinical development of similar medicinal products containing recombinant Interferon Alfa (PDF/96.73 KB)
Adopted
First published: 23/04/2009
Last updated: 23/04/2009
Legal effective date: 01/04/2009
EMEA/CHMP/BMWP/102046/2006 -
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Draft guideline on similar medicinal products containing recombinant interferon alpha (PDF/102.2 KB)
Draft: consultation closed
First published: 18/10/2007
Last updated: 18/10/2007
EMEA/CHMP/BMWP/102046/2006 -
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Concept paper on similar biological medicinal products containing recombinant Alpha-Interferon Annex to the guideline on similar biological medicinal products containing biotechnology derived protiens as active substanc... (PDF/72.16 KB)
Draft: consultation closed
First published: 26/04/2006
Last updated: 26/04/2006
CHMP/BMWP/7241/2006