2.50
Hdl Handle:
http://hdl.handle.net/10033/269352
Title:
Biosimilars: what clinicians should know.
Authors:
Weise, Martina; Bielsky, 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
Abstract:
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.
Affiliation:
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. martina.weise@bfarm.de
Citation:
Biosimilars: what clinicians should know. 2012, 120 (26):5111-7 Blood
Journal:
Blood
Issue Date:
20-Dec-2012
URI:
http://hdl.handle.net/10033/269352
DOI:
10.1182/blood-2012-04-425744
PubMed ID:
23093622
Type:
Article
Language:
en
ISSN:
1528-0020
Appears in Collections:
publications of the department of experimental infection research ([TC] EXPI)

Full metadata record

DC FieldValue Language
dc.contributor.authorWeise, Martinaen_GB
dc.contributor.authorBielsky, Marie-Christineen_GB
dc.contributor.authorDe Smet, Karenen_GB
dc.contributor.authorEhmann, Falken_GB
dc.contributor.authorEkman, Niklasen_GB
dc.contributor.authorGiezen, Thijs Jen_GB
dc.contributor.authorGravanis, Iordanisen_GB
dc.contributor.authorHeim, Hans-Karlen_GB
dc.contributor.authorHeinonen, Esaen_GB
dc.contributor.authorHo, Kowiden_GB
dc.contributor.authorMoreau, Alexandreen_GB
dc.contributor.authorNarayanan, Gopalanen_GB
dc.contributor.authorKruse, Nanna Aen_GB
dc.contributor.authorReichmann, Gabrieleen_GB
dc.contributor.authorThorpe, Robinen_GB
dc.contributor.authorvan Aerts, Leonen_GB
dc.contributor.authorVleminckx, Camilleen_GB
dc.contributor.authorWadhwa, Meenuen_GB
dc.contributor.authorSchneider, Christian Ken_GB
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.en_GB
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

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