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Review
. 2017 Jan 16;1(6):e000142.
doi: 10.1136/esmoopen-2016-000142. eCollection 2016.

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

Josep Tabernero  1 , Malvika Vyas  2 , Rosa Giuliani  3 , Dirk Arnold  4 , Fatima Cardoso  5 , Paolo G Casali  6 , Andres Cervantes  7 , Alexander M M Eggermont  8 , Alexandru Eniu  9 , Jacek Jassem  10 , George Pentheroudakis  11 , Solange Peters  12 , Stefan Rauh  13 , Christoph C Zielinski  14 , Rolf A Stahel  15 , Emile Voest  16 , Jean-Yves Douillard  2 , Keith McGregor  2 , Fortunato Ciardiello  17
Affiliations
Review

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

Josep Tabernero et al. ESMO Open. .

Abstract

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.

Keywords: Biobetters; Biosimilars; Cancer Treatment; Generics; Health Financial Burden; Non-comparable Biosimilars.

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Conflict of interest statement

Competing interests: JT serves on advisory boards for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, MSD, Merck Serono, Novartis, Pfizer, Roche, Sanofi, Symphogen, Taiho and Takeda. DA has, in the last 2 years, participated in advisory boards and/or acted as a speaker at meetings and/or recipient of travel support for participation in medical meetings for/from Roche, Merck Serono, Amgen, Bayer Healthcare, Sanofi-Aventis, Terumo and Sirtex. AC has acted as a consultant or advisor to Amgen, AstraZeneca, Sanofi-Aventis, Merck Serono, MSD, Genentech and Roche.

Comment in

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