Immunogeniciteit van biosimilars

Translated title of the contribution: Immunogenicity of biosimilars

L A G J M van Aerts, A A M Franken, H G M Leufkens

Research output: Contribution to journalArticleProfessional


Biosimilars of more complex recombinant protein drugs, such as monoclonal antibodies and fusion proteins, are entering the market. The manufacturer should demonstrate that its product does not show any relevant differences in terms of quality characteristics, biological activity, safety and efficacy compared to the reference product, as outlined in EMA guidelines. This should be established with an extensive comparability exercise. One aspect that is subject to particular scrutiny is the immunogenicity of the biosimilar and the reference medicinal product. For three cases, one etanercept and two infliximab biosimilars, we describe how data are assessed and an opinion is reached by authorities. Not in all cases unanimity exists whether all remaining uncertainties on biosimilarity have been resolved satisfactorily before marketing authorisation. The Dutch Medicines Evaluation Board therefore emphasises that even after marketing authorisation, biosimilars and other biologicals should be properly monitored.

Translated title of the contributionImmunogenicity of biosimilars
Original languageDutch
Article numberD888
Number of pages4
JournalNederlands Tijdschrift voor Geneeskunde
Publication statusPublished - 16 Dec 2016


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