Cargando…

An update on the clinical evidence that supports biosimilar approvals in Europe

AIM: Sponsors and regulators have more than 10 years of experience with the development of biosimilars in Europe. However, the regulatory pathway is still evolving. The present article provides an update on biosimilar development in practice by reviewing the clinical development programmes of recent...

Descripción completa

Detalles Bibliográficos
Autores principales: Mielke, Johanna, Jilma, Bernd, Jones, Byron, Koenig, Franz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6005614/
https://www.ncbi.nlm.nih.gov/pubmed/29575017
http://dx.doi.org/10.1111/bcp.13586