The changing landscape of biosimilars in rheumatology
Identifieur interne : 000004 ( Pmc/Checkpoint ); précédent : 000003; suivant : 000005The changing landscape of biosimilars in rheumatology
Auteurs : Thomas Dörner [Allemagne] ; Vibeke Strand [États-Unis] ; Paul Cornes [Royaume-Uni] ; João Gonçalves [Portugal] ; Lászl Gulácsi [Hongrie] ; Jonathan Kay [États-Unis] ; Tore K. Kvien [Norvège] ; Josef Smolen [Autriche] ; Yoshiya Tanaka [Japon] ; Gerd R. Burmester [Allemagne]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2016.
Abstract
Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.
Url:
DOI: 10.1136/annrheumdis-2016-209166
PubMed: 26964144
PubMed Central: 4893105
Affiliations:
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PMC:4893105Le document en format XML
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<front><div type="abstract" xml:lang="en"><p>Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.</p>
</div>
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<pmc article-type="review-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id>
<journal-id journal-id-type="iso-abbrev">Ann. Rheum. Dis</journal-id>
<journal-id journal-id-type="hwp">annrheumdis</journal-id>
<journal-id journal-id-type="publisher-id">ard</journal-id>
<journal-title-group><journal-title>Annals of the Rheumatic Diseases</journal-title>
</journal-title-group>
<issn pub-type="ppub">0003-4967</issn>
<issn pub-type="epub">1468-2060</issn>
<publisher><publisher-name>BMJ Publishing Group</publisher-name>
<publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26964144</article-id>
<article-id pub-id-type="pmc">4893105</article-id>
<article-id pub-id-type="publisher-id">annrheumdis-2016-209166</article-id>
<article-id pub-id-type="doi">10.1136/annrheumdis-2016-209166</article-id>
<article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject>
</subj-group>
<subj-group subj-group-type="heading"><subject>Review</subject>
</subj-group>
</article-categories>
<title-group><article-title>The changing landscape of biosimilars in rheumatology</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Dörner</surname>
<given-names>Thomas</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Strand</surname>
<given-names>Vibeke</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Cornes</surname>
<given-names>Paul</given-names>
</name>
<xref ref-type="aff" rid="af4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gonçalves</surname>
<given-names>João</given-names>
</name>
<xref ref-type="aff" rid="af5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gulácsi</surname>
<given-names>László</given-names>
</name>
<xref ref-type="aff" rid="af6">6</xref>
</contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0002-8970-4260</contrib-id>
<name><surname>Kay</surname>
<given-names>Jonathan</given-names>
</name>
<xref ref-type="aff" rid="af7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kvien</surname>
<given-names>Tore K</given-names>
</name>
<xref ref-type="aff" rid="af8">8</xref>
</contrib>
<contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0002-8899-9087</contrib-id>
<name><surname>Smolen</surname>
<given-names>Josef</given-names>
</name>
<xref ref-type="aff" rid="af9">9</xref>
<xref ref-type="aff" rid="af10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Tanaka</surname>
<given-names>Yoshiya</given-names>
</name>
<xref ref-type="aff" rid="af11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Burmester</surname>
<given-names>Gerd R</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
</contrib>
</contrib-group>
<aff id="af1"><label>1</label>
<addr-line>Department of Medicine/Rheumatology and Clinical Immunology</addr-line>
,<institution>Charité Universitätsmedizin</institution>
,<addr-line>Berlin</addr-line>
,<country>Germany</country>
</aff>
<aff id="af2"><label>2</label>
<institution>Deutsches Rheumaforschungszentrum (DRFZ)</institution>
,<addr-line>Berlin</addr-line>
,<country>Germany</country>
</aff>
<aff id="af3"><label>3</label>
<addr-line>Division Immunology/Rheumatology</addr-line>
,<institution>Stanford University School of Medicine</institution>
,<addr-line>Palo Alto, California</addr-line>
,<country>USA</country>
</aff>
<aff id="af4"><label>4</label>
<addr-line>Comparative Outcomes Group, Bristol</addr-line>
,<country>UK</country>
</aff>
<aff id="af5"><label>5</label>
<addr-line>Faculty of Pharmacy at University of Lisbon</addr-line>
,<institution>iMed- Research Institute for Medicines</institution>
,<country>Portugal</country>
</aff>
<aff id="af6"><label>6</label>
<addr-line>Department of Health Economics</addr-line>
,<institution>Corvinus University of Budapest</institution>
,<addr-line>Budapest</addr-line>
,<country>Hungary</country>
</aff>
<aff id="af7"><label>7</label>
<addr-line>Division of Rheumatology, Department of Medicine</addr-line>
,<institution>University of Massachusetts Medical School and UMass Memorial Medical Center</institution>
,<addr-line>Worcester, Massachusetts</addr-line>
,<country>USA</country>
</aff>
<aff id="af8"><label>8</label>
<addr-line>Department of Rheumatology</addr-line>
,<institution>Diakonhjemmet Hospital</institution>
,<addr-line>Oslo</addr-line>
,<country>Norway</country>
</aff>
<aff id="af9"><label>9</label>
<addr-line>Division of Rheumatology, Department of Medicine 3</addr-line>
,<institution>Medical University of Vienna</institution>
,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</aff>
<aff id="af10"><label>10</label>
<addr-line>Department of Medicine</addr-line>
,<institution>Hietzing Hospital</institution>
,<addr-line>Vienna</addr-line>
,<country>Austria</country>
</aff>
<aff id="af11"><label>11</label>
<addr-line>The First Department of Internal Medicine</addr-line>
,<institution>School of Medicine</institution>
,<institution>University of Occupational and Environmental Health</institution>
,<addr-line>Kitakyushu</addr-line>
,<country>Japan</country>
</aff>
<author-notes><fn><p><bold>Handling editor</bold>
Hans WJ Bijlsma</p>
</fn>
<corresp><label>Correspondence to</label>
Professor Thomas Dörner, Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin &DRFZ Berlin, Chariteplatz 01, Berlin 10117, Germany; <email>thomas.doerner@charite.de</email>
</corresp>
<fn><p>TD and VS shared first authorship.</p>
</fn>
</author-notes>
<pub-date pub-type="ppub"><month>6</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub"><day>8</day>
<month>3</month>
<year>2016</year>
</pub-date>
<volume>75</volume>
<issue>6</issue>
<fpage>974</fpage>
<lpage>982</lpage>
<history><date date-type="received"><day>11</day>
<month>1</month>
<year>2016</year>
</date>
<date date-type="rev-recd"><day>17</day>
<month>2</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>18</day>
<month>2</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/</copyright-statement>
<copyright-year>2016</copyright-year>
<license license-type="open-access"><license-p>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link>
</license-p>
</license>
</permissions>
<self-uri xlink:title="pdf" xlink:href="annrheumdis-2016-209166.pdf"></self-uri>
<abstract><p>Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.</p>
</abstract>
<kwd-group><kwd>Rheumatoid Arthritis</kwd>
<kwd>Economic Evaluations</kwd>
<kwd>DMARDs (biologic)</kwd>
<kwd>Treatment</kwd>
<kwd>Anti-TNF</kwd>
</kwd-group>
<funding-group specific-use="FundRef"><award-group id="funding-1"><funding-source><institution-wrap><institution>F. Hoffman-La Roche</institution>
<institution-id>http://dx.doi.org/10.13039/100007013</institution-id>
</institution-wrap>
</funding-source>
</award-group>
</funding-group>
<custom-meta-group><custom-meta><meta-name>special-feature</meta-name>
<meta-value>unlocked</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Allemagne</li>
<li>Autriche</li>
<li>Hongrie</li>
<li>Japon</li>
<li>Norvège</li>
<li>Portugal</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
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<tree><country name="Allemagne"><noRegion><name sortKey="Dorner, Thomas" sort="Dorner, Thomas" uniqKey="Dorner T" first="Thomas" last="Dörner">Thomas Dörner</name>
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