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

AdoptedReference Number: EMA/CHMP/BMWP/652000/2010Summary:

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

AdoptedReference Number: EMA/CHMP/BMWP/652000/2010Summary:

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

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

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

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