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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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| Published in: | Drug Des Devel Ther |
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| Main Authors: | , , |
| Format: | Artigo |
| Language: | Inglês |
| Published: |
Dove Medical Press
2017
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| Subjects: | |
| Online Access: | 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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