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Ten years of biosimilars in Europe: development and evolution of the regulatory pathways

A biosimilar is defined by the European Medicines Agency as a biological medicine that is similar to another biological medicine that has already been authorized for use. A science-based regulatory framework to ensure high-quality biosimilars has been established in Europe since 2005 and is monitore...

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Détails bibliographiques
Publié dans:Drug Des Devel Ther
Auteurs principaux: Schiestl, Martin, Zabransky, Markus, Sörgel, Fritz
Format: Artigo
Langue:Inglês
Publié: Dove Medical Press 2017
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC5440034/
https://ncbi.nlm.nih.gov/pubmed/28553082
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/DDDT.S130318
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