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dc.contributor.authorWeise, Martina
dc.contributor.authorBielsky, Marie-Christine
dc.contributor.authorDe Smet, Karen
dc.contributor.authorEhmann, Falk
dc.contributor.authorEkman, Niklas
dc.contributor.authorGiezen, Thijs J
dc.contributor.authorGravanis, Iordanis
dc.contributor.authorHeim, Hans-Karl
dc.contributor.authorHeinonen, Esa
dc.contributor.authorHo, Kowid
dc.contributor.authorMoreau, Alexandre
dc.contributor.authorNarayanan, Gopalan
dc.contributor.authorKruse, Nanna A
dc.contributor.authorReichmann, Gabriele
dc.contributor.authorThorpe, Robin
dc.contributor.authorvan Aerts, Leon
dc.contributor.authorVleminckx, Camille
dc.contributor.authorWadhwa, Meenu
dc.contributor.authorSchneider, Christian K
dc.date.accessioned2013-02-13T13:13:43Z
dc.date.available2013-02-13T13:13:43Z
dc.date.issued2012-12-20
dc.identifier.citationBiosimilars: what clinicians should know. 2012, 120 (26):5111-7 Blooden_GB
dc.identifier.issn1528-0020
dc.identifier.pmid23093622
dc.identifier.doi10.1182/blood-2012-04-425744
dc.identifier.urihttp://hdl.handle.net/10033/269352
dc.description.abstractBiosimilar 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.
dc.language.isoenen
dc.rightsArchived with thanks to Blooden_GB
dc.titleBiosimilars: what clinicians should know.en
dc.typeArticleen
dc.contributor.departmentBundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. martina.weise@bfarm.deen_GB
dc.identifier.journalBlooden_GB
refterms.dateFOA2018-06-12T20:04:31Z
html.description.abstractBiosimilar 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.


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