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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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Détails bibliographiques
Publié dans:Int J Clin Pharm
Auteurs principaux: Francescon, Sara, Fornasier, Giulia, Baldo, Paolo
Format: Artigo
Langue:Inglês
Publié: Springer International Publishing 2018
Sujets:
Accès en ligne: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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