Biosimilars : a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers
Tabernero, Josep (Vall d'Hebron Institut d'Oncologia)
Vyas, Malvika (European Society for Medical Oncology)
Giuliani, Rosa (San Camillo Forlanini Hospital)
Arnold, Dirk (CUF Hospitals)
Cardoso, Fatima (Champalimaud Clinical Center)
Casali, Paolo Giovanni (Fondazione IRCCS National Cancer Institute)
Cervantes, Andrés (Clinic Hospital)
Eggermont, Alexander (Gustave Roussy Cancer Campus Grand Paris)
Eniu, Alexandru (Cancer Institute "Ion Chiricuta")
Jassem, Jacek (Medical University of Gdansk)
Pentheroudakis, George (University of Ioannina)
Peters, Solange (Centre Hospitalier Universitaire Vaudois)
Rauh, Stefan (Hospital Center Emile Mayrisch)
Zielinski, Christoph C. (Medical University of Vienna)
Stahel, Rolf A. (The Netherlands Cancer Institute (Amsterdam, Països Baixos))
Voest, Emile (University Hospital Zurich (Suïssa))
Douillard, Jean-Yves (European Society for Medical Oncology)
McGregor, Keith (European Society for Medical Oncology)
Ciardiello, Fortunato (Second University of Naples)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Biosimilars ; Generics ; Cancer Treatment ; Health Financial Burden ; Biobetters ; Non-comparable Biosimilars
Publicat a:	ESMO open, Vol. 1 (january 2017) , ISSN 2059-7029

DOI: 10.1136/esmoopen-2016-000142
PMID: 28848668

5 p, 332.1 KB

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