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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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Bibliografische gegevens
Gepubliceerd in:BioDrugs
Hoofdauteurs: Grampp, Gustavo, Felix, Thomas
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: Springer International Publishing 2015
Onderwerpen:
Online toegang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4626527/
https://ncbi.nlm.nih.gov/pubmed/26419971
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-015-0137-2
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