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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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Dettagli Bibliografici
Pubblicato in:Int J Clin Pharm
Autori principali: Francescon, Sara, Fornasier, Giulia, Baldo, Paolo
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer International Publishing 2018
Soggetti:
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC6132979/
https://ncbi.nlm.nih.gov/pubmed/30094558
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11096-018-0709-6
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