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EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies

An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicoche...

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Detalles Bibliográficos
Autores principales: Francescon, Sara, Fornasier, Giulia, Baldo, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132979/
https://www.ncbi.nlm.nih.gov/pubmed/30094558
http://dx.doi.org/10.1007/s11096-018-0709-6