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

被引：88

作者：

Tabernero, Josep ^{[1
,2
]}

Vyas, Malvika ^{[3
]}

Giuliani, Rosa ^{[4
]}

Arnold, Dirk ^{[5
]}

Cardoso, Fatima ^{[6
]}

Casali, Paolo G. ^{[7
]}

Cervantes, Andres ^{[8
]}

Eggermont, Alexander M. M. ^{[9
]}

Eniu, Alexandru ^{[10
]}

Jassem, Jacek ^{[11
]}

Pentheroudakis, George ^{[12
]}

Peters, Solange ^{[13
]}

Rauh, Stefan ^{[14
]}

Zielinski, Christoph C. ^{[15
]}

Stahel, Rolf A. ^{[16
]}

Voest, Emile ^{[17
]}

Douillard, Jean-Yves ^{[3
]}

McGregor, Keith ^{[3
]}

Ciardiello, Fortunato ^{[18
]}

机构：

[1] Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Barcelona, Spain

[2] Univ Autonoma Barcelona, VHIO, Barcelona, Spain

[3] European Soc Med Oncol, Lugano, Switzerland

[4] San Camillo Forlanini Hosp, Med Oncol, Rome, Italy

[5] CUF Hosp, Canc Ctr, Lisbon, Portugal

[6] Champalimaud Clin Ctr, Breast Unit, Lisbon, Portugal

[7] Fondaz IRCCS Natl Canc Inst, Milan, Italy

[8] Clin Hosp, Hematol Med Oncol Dept, Valencia, Spain

[9] Gustave Roussy Canc Campus Grand Paris, Villejuif, France

[10] Canc Inst Ion Chiricuta, Dept Breast Tumors, Cluj Napoca, Romania

[11] Med Univ Gdansk, Dept Oncol & Radiotherapy, Gdansk, Poland

[12] Univ Ioannina, Ioannina, Greece

[13] Univ Vaudois, Ctr Hospitalier, Oncol Dept, Lausanne, Switzerland

[14] Hosp Ctr Emile Mayrisch, Dept Hemato Oncol, Esch Sur Alzette, Luxembourg

[15] Med Univ Vienna, Dept Med 1, Clin Div Oncol, Vienna, Austria

[16] Netherlands Canc Inst, Amsterdam, Netherlands

[17] Univ Hosp Zurich, Zurich, Switzerland

[18] Univ Naples 2, Naples, Italy

来源：

ESMO OPEN | 2016年 / 1卷 / 06期

关键词：

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

D O I：

10.1136/esmoopen-2016-000142

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页数：5

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