title: Biosimilar regulation in the EU.
abstract: 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 No biosimilars have been withdrawn from the market because of safety concerns.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.
authors: a Evaluation of medicinal products, Finnish Medicines Agency, Mannerheimintie 103b, P.O. Box 55, 00301 Helsinki, Finland.
authors: Pekka
authors: P
authors: Kurki
authors: Niklas
authors: N
authors: Ekman
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: biosimilars; clinical trials; comparability; extrapolation; immunogenicity; interchangeability; regulatory