EMA issues revised guideline on non-clinical and clinical issues for biosimilars

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EMA issues revised guideline on non-clinical and clinical issues for biosimilars

Home/Guidelines | Posted 16/01/2015 0 Post your comment

On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.

The guideline outlines the non-clinical and clinical requirements for marketing authorization of a biosimilar claiming to be similar to a biological product already marketed. The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and efficacy studies. The section on clinical safety and pharmacovigilance addresses clinical safety studies, including immunogenicity, as well as the risk management plan.

The current revision covers the following topics:

a stepwise approach for the design of non-clinical studies
the use of pharmacodynamic markers
study design, choice of appropriate patient population and choice of surrogate and clinical endpoints in efficacy trials
clinical safety (including design of immunogenicity studies), risk management plan and pharmacovigilance, and extrapolation of safety and efficacy.

The guideline recommends a stepwise conduct of non-clinical and clinical studies.

The guideline replaces EMA’s ‘Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues’ (EMEA/CHMP/BMWP/42832/2005).

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues
EMEA/CHMP/BMWP/42832/2005 Rev1
Effective date: 1 July 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf

EMA published the new version of its biosimilars quality guideline on 26 June 2014 [1] and of its overarching biosimilars guideline on 29 October 2014 [2].

EMA issues draft revision of overarching biosimilar guidelines

EU guidelines for biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of biosimilars quality guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-biosimilars-quality-guideline
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of overarching biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 16]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-overarching-biosimilars-guideline

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Source: EMA