The 'Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins' (EMEA/CHMP/BMWP/14327/2006) came into effect in April 2008. This guideline laid down general recommendations for the performance of a systematic immunogenicity assessment from a marketing authorization perspective. Since then, EMA has also released a guideline covering immunogenicity assessment for monoclonal antibodies.

The guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use (EMA/CHMP/BMWP/86289/2010) came into force in December 2012.

Since these guidelines on immunogenicity were introduced, considerable knowledge has accumulated on assays, risk factors, and the potential consequences of unwanted immune responses such as loss of efficacy, hypersensitivity and cross-reactivity with endogenous protein. In addition, comparisons of the immunogenicity of two versions of a product or two independent products, e.g. a biosimilar and its reference product, have certain specific aspects that need discussion. All these factors, according to the Biosimilar Medicinal Products Working Party (BMWP), which prepared this concept paper, need to be considered when updating and revising the current guideline.

The BMWP is therefore conducting a public consultation on the revision of the guideline, from which the Committee hopes to address the following topics:

• More specific guidance for the presentation of immunogenicity data
• Requirements of data on antibody assays
• Role of in vitro and in vivo non-clinical studies
• Risk-based approach to immunogenicity
• Clinical data to study the correlations of the induced antibodies to allergic and anaphylactic/anaphylactoid reactions, delayed immunological reactions, pharmacokinetics, lack of efficacy
• Comparative immunogenicity studies
• Post-licensing immunological studies

Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteinsCHMP/BMWP/42832/2005
Date: 20 February 2014
Released for consultation: 25 March 2014
End of consultation: 30 June 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/03/WC500163623.pdf

EMA states that the aim of the revision is not to increase the number of studies on immunogenicity, but to increase the quality of studies and their clarity to the assessors.

Feedback on the concept paper can be submitted to bmwp.secretariat@ema.europa.eu until 30 June 2014. EMA expects to release the draft revised guideline for consultation in the fourth quarter of 2014

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