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

Current effective version - Under revision - see below

Reflection paper: Non-clinical and clinical development of similar medicinal products containing recombinant Interferon Alfa

Adopted Reference Number: EMEA/CHMP/BMWP/102046/2006 Legal effective date: 01/04/2009

Document history - Revision 1 (in progress)

Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon al...

Draft: consultation closed Consultation dates: 04/01/2016 to 31/03/2016 Reference Number: EMA/CHMP/BMWP/693108/2015 Summary:

The current reflection paper on similar medicinal products containing recombinant interferon alpha provides recommendations for the non-clinical and clinical development of recombinant interferon alpha claimed to be similar to a reference product already authorised in the European Union (EU). This reflection paper was published in April 2009. Since then, no products containing biosimilar interferon alpha have been licensed in the EU. It is proposed to update the guidance based on the experience gained with marketing authorisation applications of reference products and scientific advice on biosimilar interferon alpha.

Document history - First version (current)

Reflection paper: Non-clinical and clinical development of similar medicinal products containing recombinant Interferon Alfa

Adopted Reference Number: EMEA/CHMP/BMWP/102046/2006 Legal effective date: 01/04/2009

Draft guideline on similar medicinal products containing recombinant interferon alpha

Draft: consultation closed Reference Number: EMEA/CHMP/BMWP/102046/2006

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...

Draft: consultation closed Reference Number: CHMP/BMWP/7241/2006