Biosimilars: what clinicians should know

被引：263

作者：

Weise, Martina ^{[1
]}

Bielsky, Marie-Christine ^{[2
]}

De Smet, Karen ^{[3
]}

Ehmann, Falk ^{[4
]}

Ekman, Niklas ^{[5
]}

Giezen, Thijs J. ^{[6
]}

Gravanis, Iordanis ^{[4
]}

Heim, Hans-Karl

Heinonen, Esa ^{[5
]}

Ho, Kowid ^{[7
]}

Moreau, Alexandre ^{[7
]}

Narayanan, Gopalan ^{[2
]}

Kruse, Nanna A. ^{[8
]}

Reichmann, Gabriele ^{[9
]}

Thorpe, Robin ^{[10
]}

van Aerts, Leon ^{[11
]}

Vleminckx, Camille ^{[4
]}

Wadhwa, Meenu ^{[10
]}

Schneider, Christian K. ^{[8
,12
]}

机构：

[1] Fed Inst Drugs & Med Devices, Unit Diabet Cardiovasc Disorders, D-53175 Bonn, Germany

[2] Med & Healthcare Prod Regulatory Agcy, London, England

[3] Fed Agcy Med & Hlth Prod, Brussels, Belgium

[4] European Med Agcy, London, England

[5] Finnish Med Agcy, Helsinki, Finland

[6] Med Spectrum Twente, Dept Clin Pharm, Amsterdam, Netherlands

[7] Agence Natl Secur Med & Prod Sante, Paris, France

[8] Danish Hlth & Med Author, Copenhagen, Denmark

[9] Paul Ehrlich Inst, Langen, Germany

[10] Natl Inst Biol Stand & Controls, Potters Bar, Herts, England

[11] Med Evaluat Board, Utrecht, Netherlands

[12] Twincore Ctr Expt & Clin Infect Res, Hannover, Germany

来源：

BLOOD | 2012年 / 120卷 / 26期

关键词：

POSITION PAPER; EPOETIN; BIOPHARMACEUTICALS; IMMUNOGENICITY; NEEDS;

D O I：

10.1182/blood-2012-04-425744

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators. (Blood. 2012; 120(26): 5111-5117)

引用

页码：5111 / 5117

页数：7

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