Biosimilar regulation in the EU

In the EU, the EMA has been working with biosimilars since 1998. This experience is crystallized in the extensive set of guidelines, which range from basic principles to details of clinical trials. While the guidance may appear complicated, it has enabled the development of biosimilars, of which 21...

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Bibliographic Details
Published inExpert review of clinical pharmacology Vol. 8; no. 5; p. 649
Main Authors Kurki, Pekka, Ekman, Niklas
Format Journal Article
LanguageEnglish
Published England 03.09.2015
Subjects
Animals
Biosimilar Pharmaceuticals - standards
Drug Approval - legislation & jurisprudence
Drug Design
European Union
Guidelines as Topic
Humans
Legislation, Drug
interchangeability
extrapolation
comparability
biosimilars
regulatory
clinical trials
immunogenicity
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Summary:In the EU, the EMA has been working with biosimilars since 1998. This experience is crystallized in the extensive set of guidelines, which range from basic principles to details of clinical trials. While the guidance may appear complicated, it has enabled the development of biosimilars, of which 21 have managed to get marketing authorization. Currently marketed biosimilars in the EU have a good track record in safety and traceability. No biosimilars have been withdrawn from the market because of safety concerns. The most controversial issues with biosimilars are immunogenicity and extrapolation of therapeutic indications. The available data for these topics do not raise concerns among EU regulators. Interchangeability and substitution are regulated by individual EU member states.
ISSN:1751-2441
DOI:10.1586/17512433.2015.1071188