Similar biological medicinal products containing interferon beta - Scientific guideline
Table of contents
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
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Guideline on similar biological medicinal products containing interferon beta (PDF/145.95 KB)
Adopted
First published: 06/03/2013
Last updated: 06/03/2013
EMA/CHMP/BMWP/652000/2010 -
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Overview of comments received on guideline on similar biological medicinal products containing interferon beta (EMA/CHMP/BMWP/652000/2010) (PDF/443.7 KB)
First published: 06/03/2013
Last updated: 06/03/2013
EMA/608526/2012 -
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Draft guideline on similar biological medicinal products containing interferon beta (PDF/154.62 KB)
Draft: consultation closed
First published: 19/01/2012
Last updated: 19/01/2012
Consultation dates: 15/12/2011 to 31/05/2012
EMA/CHMP/BMWP/652000/2010 -
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Concept paper on similar biological product containing recombinant interferon beta (PDF/178.58 KB)
Draft: consultation closed
First published: 06/04/2010
Last updated: 06/04/2010
Consultation dates: 18/03/2010 to 11/06/2010
EMA/CHMP/BMWP/86572/2010
- Multidisciplinary: biosimilar
- Directive 2001/83/EC
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Biologics Working Party Report to the CHMP Beta-interferons and neutralising antibodies (in multiple sclerosis)
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Good pharmacovigilance practices (GVP) module V – risk management systems
- Clinical investigation of medicinal products for the treatment of multiple sclerosis
- Clinical investigation of the pharmacokinetics of therapeutic proteins
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Immunogenicity assessment of biotechnology-derived therapeutic proteins
- Investigation of bioequivalence
- Similar biological medicinal products
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues