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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...

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Detalles Bibliográficos
Autores principales: Grampp, Gustavo, Felix, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
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