Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community

Biosimilars are highly similar versions of approved branded biologics. Unlike generics, they are not exact replicas of reference products. Minor differences between biosimilars and reference products in some aspects are expected; likewise, biosimilar products will differ from each other. The objecti...

Полное описание

Сохранить в:
Библиографические подробности
Опубликовано в: :BioDrugs
Главные авторы: Markus, Richard, Liu, Jennifer, Ramchandani, Monica, Landa, Diana, Born, Teresa, Kaur, Primal
Формат: Artigo
Язык:Inglês
Опубликовано: Springer International Publishing 2017
Предметы:
Review Article
Online-ссылка:https://ncbi.nlm.nih.gov/pmc/articles/PMC5443883/
https://ncbi.nlm.nih.gov/pubmed/28439817
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-017-0218-5
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