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Pharmacovigilance Considerations for Biosimilars in the USA
In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety mon...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2015
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4626527/ https://www.ncbi.nlm.nih.gov/pubmed/26419971 http://dx.doi.org/10.1007/s40259-015-0137-2 |