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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Dove Medical Press
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5440034/ https://www.ncbi.nlm.nih.gov/pubmed/28553082 http://dx.doi.org/10.2147/DDDT.S130318 |