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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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Bibliografiske detaljer
Udgivet i:Int J Clin Pharm
Main Authors: Francescon, Sara, Fornasier, Giulia, Baldo, Paolo
Format: Artigo
Sprog:Inglês
Udgivet: Springer International Publishing 2018
Fag:
Online adgang: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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