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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...
Autores principales: | Francescon, Sara, Fornasier, Giulia, Baldo, Paolo |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2018
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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 |
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