Biosimilars: Key regulatory considerations and similarity assessment tools

A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which t...

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Detalles Bibliográficos
Autores principales: Kirchhoff, Carol F., Wang, Xiao‐Zhuo Michelle, Conlon, Hugh D., Anderson, Scott, Ryan, Anne M., Bose, Arindam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698755/
https://www.ncbi.nlm.nih.gov/pubmed/28842986
http://dx.doi.org/10.1002/bit.26438

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698755/
https://www.ncbi.nlm.nih.gov/pubmed/28842986
http://dx.doi.org/10.1002/bit.26438

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