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Authors
Weise, MartinaBielsky, Marie-Christine
De Smet, Karen
Ehmann, Falk
Ekman, Niklas
Giezen, Thijs J
Gravanis, Iordanis
Heim, Hans-Karl
Heinonen, Esa
Ho, Kowid
Moreau, Alexandre
Narayanan, Gopalan
Kruse, Nanna A
Reichmann, Gabriele
Thorpe, Robin
van Aerts, Leon
Vleminckx, Camille
Wadhwa, Meenu
Schneider, Christian K
Issue Date
2012-12-20
Metadata
Show full item recordAbstract
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.Citation
Biosimilars: what clinicians should know. 2012, 120 (26):5111-7 BloodAffiliation
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. martina.weise@bfarm.deJournal
BloodPubMed ID
23093622Type
ArticleLanguage
enISSN
1528-0020ae974a485f413a2113503eed53cd6c53
10.1182/blood-2012-04-425744
Scopus Count
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