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...

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Detalles Bibliográficos
Autores principales: Markus, Richard, Liu, Jennifer, Ramchandani, Monica, Landa, Diana, Born, Teresa, Kaur, Primal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443883/
https://www.ncbi.nlm.nih.gov/pubmed/28439817
http://dx.doi.org/10.1007/s40259-017-0218-5

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443883/
https://www.ncbi.nlm.nih.gov/pubmed/28439817
http://dx.doi.org/10.1007/s40259-017-0218-5

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