Cargando…
The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders
Biosimilars are required to be similar or highly similar in structure to their biologic reference product but are neither expected nor required to contain identical active substances. For example, glycosylated biosimilars approved to date demonstrate quantitative and qualitative structural differenc...
Autores principales: | Grampp, Gustavo, Ramanan, Sundar |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684584/ https://www.ncbi.nlm.nih.gov/pubmed/26581551 http://dx.doi.org/10.1007/s40259-015-0147-0 |
Ejemplares similares
-
Pharmacovigilance Considerations for Biosimilars in the USA
por: Grampp, Gustavo, et al.
Publicado: (2015) -
An Efficient Development Paradigm for Biosimilars
por: Webster, Christopher J., et al.
Publicado: (2019) -
Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching
por: Husereau, Don, et al.
Publicado: (2018) -
A ‘Global Reference’ Comparator for Biosimilar Development
por: Webster, Christopher J., et al.
Publicado: (2017) -
Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective
por: Cohen, Hillel P., et al.
Publicado: (2023)