Similar biological medicinal products containing interferon beta - Scientific guideline

This document lays down the non-clinical and clinical requirements for interferon beta (IFN-β) containing medicinal products claiming to be similar to another interferon beta already marketed.

Keywords: Interferon beta, similar biological medicinal product, biosimilar, comparability, non-clinical studies, clinical studies

Current effective version

Guideline on similar biological medicinal products containing interferon beta

Adopted Reference Number: EMA/CHMP/BMWP/652000/2010 Summary:

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β)

containing medicinal products claiming to be similar to another interferon beta already marketed. The

non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the

requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as

pharmacovigilance aspects.

Document history - First version (current)

Guideline on similar biological medicinal products containing interferon beta

Adopted Reference Number: EMA/CHMP/BMWP/652000/2010 Summary:

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β)

containing medicinal products claiming to be similar to another interferon beta already marketed. The

non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the

requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as

pharmacovigilance aspects.

Overview of comments received on guideline on similar biological medicinal products containing interferon beta (EMA/CHMP/BMWP/652000/2010)

Reference Number: EMA/608526/2012

Draft guideline on similar biological medicinal products containing interferon beta

Draft: consultation closed Consultation dates: 15/12/2011 to 31/05/2012 Reference Number: EMA/CHMP/BMWP/652000/2010 Summary:

This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β) containing medicinal products claiming to be similar to another interferon beta already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.

Concept paper on similar biological product containing recombinant interferon beta

Draft: consultation closed Consultation dates: 18/03/2010 to 11/06/2010 Reference Number: EMA/CHMP/BMWP/86572/2010