The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics

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<main class="article-details" id="article-details">   <header class="heading" id="heading"> <div class="full-view" id="full-view-heading"> <div class="article-citation"> <div class="article-source"> <div class="journal-actions dropdown-block"><button id="full-view-journal-trigger" class="journal-actions-trigger trigger" ref="linksrc=journal_actions_btn" title="Statistics in medicine" tabindex="0" aria-controls="full-view-journal" aria-expanded="false" aria-label="Toggle dropdown menu for journal Statistics in medicine" data-pinger-ignore> Stat Med </button><div id="full-view-journal" class="journal-actions-dropdown dropdown dropdown-container" hidden aria-label="Dropdown menu for journal Statistics in medicine"><div class="title">Actions</div><div class="content"><ul class="journal-actions-links"><li><a class="search-in-pubmed-link dropdown-block-link" href="/?term=%22Stat+Med%22%5Bjour%5D&sort=date&sort_order=desc" data-href="/?term=%22Stat+Med%22%5Bjour%5D&sort=date&sort_order=desc" 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class="heading-title"> The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics </h1> <div class="inline-authors"> <div class="authors"> <div class="authors-list"> <span class="authors-list-item "><a class="full-name" href="/?term=Hsieh+TC&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Tsung-Cheng Hsieh">Tsung-Cheng Hsieh</a><sup class="affiliation-links"><span class="author-sup-separator"> </span><a class="affiliation-link" title="Institute of Medical Sciences, Tzu Chi University, Hualien, Taiwan." href="#full-view-affiliation-1" ref="linksrc=author_aff"> 1 </a></sup><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Chow+SC&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Shein-Chung Chow">Shein-Chung Chow</a><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Yang+LY&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Lan-Yan Yang">Lan-Yan Yang</a><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Chi+E&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Eric Chi">Eric Chi</a></span> </div> </div> </div> <div class="short-article-details"> Affiliations <button class="more-details" id="toggle-authors" data-alt-text="Collapse" aria-controls="expanded-authors" aria-expanded="false" data-pinger-ignore data-fetch-url="/22899403/long-authors/" data-id-prefix=""> <span class="title"> Expand </span> </button> </div> <div class="extended-article-details" id="expanded-authors" aria-hidden="true"> <div class="expanded-authors" id="full-view-expanded-authors"> <div class="affiliations"> <h3 class="title"> Affiliation </h3> <ul class="item-list"> <li data-affiliation-id="full-view-affiliation-1" id="full-view-affiliation-1" ><sup class="key">1</sup> Institute of Medical Sciences, Tzu Chi University, Hualien, Taiwan.</li> </ul> </div> </div> </div> <ul class="identifiers" id="full-view-identifiers"> <li> <span class="identifier pubmed"> <span class="id-label"> PMID: </span> <strong class="current-id" title="PubMed ID">22899403</strong> </span> </li> <li> <span class="identifier doi"> <span class="id-label"> DOI: </span> <a class="id-link" target="_blank" rel="noopener" ref="linksrc=article_id_link&article_id=10.1002/sim.5570&id_type=DOI" href="https://doi.org/10.1002/sim.5570" data-ga-category="full_text" data-ga-action="DOI" > 10.1002/sim.5570 </a> </span> </li> </ul> <div class="in-clipboard-label " hidden> Item in Clipboard </div> </div> <div class="short-view" id="short-view-heading"> <h1 class="heading-title"> The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics </h1> <div class="short-citation"> <span class="authors-list"> <span class="authors-list-item "><span class="full-name">Tsung-Cheng Hsieh</span><span class="citation-separator"> et al.</span></span> </span> <span class="citation-journal"> Stat Med<span class="citation-separator">.</span> </span> <span class="date"> <time class="citation-year" datetime="2013">2013</time><span class="citation-separator">.</span> </span> </div> <div class="more-article-details-section with-display-settings"> <button class="more-article-details" id="toggle-article-details" data-alt-text="Hide details" ref="linksrc=toggle_article_details" aria-controls="full-article-details" aria-expanded="false" data-fetch-url="/22899403/long-authors/" data-id-prefix=""> <span class="title">Show details</span> </button> <div class="display-options" data-format-key="format" data-default-format-value="abstract" data-current-format-value="abstract" 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Hsieh</a><sup class="affiliation-links"><span class="author-sup-separator"> </span><a class="affiliation-link" title="Institute of Medical Sciences, Tzu Chi University, Hualien, Taiwan." href="#short-view-affiliation-1" ref="linksrc=author_aff"> 1 </a></sup><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Chow+SC&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Shein-Chung Chow">Shein-Chung Chow</a><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Yang+LY&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Lan-Yan Yang">Lan-Yan Yang</a><span class="comma">, </span></span><span class="authors-list-item "><a class="full-name" href="/?term=Chi+E&cauthor_id=22899403" ref="linksrc=author_name_link" data-ga-category="search" data-ga-action="author_link" data-ga-label="Eric Chi">Eric Chi</a></span> </div> </div> <div class="affiliations"> <h3 class="title"> Affiliation </h3> <ul class="item-list"> <li data-affiliation-id="short-view-affiliation-1" id="short-view-affiliation-1" ><sup class="key">1</sup> Institute of Medical Sciences, Tzu Chi University, Hualien, Taiwan.</li> </ul> </div> </div> <ul class="identifiers" id="short-view-identifiers"> <li> <span class="identifier pubmed"> <span class="id-label"> PMID: </span> <strong class="current-id" title="PubMed ID">22899403</strong> </span> </li> <li> <span class="identifier doi"> <span class="id-label"> DOI: </span> <a class="id-link" target="_blank" rel="noopener" ref="linksrc=article_id_link&article_id=10.1002/sim.5570&id_type=DOI" href="https://doi.org/10.1002/sim.5570" data-ga-category="full_text" data-ga-action="DOI" > 10.1002/sim.5570 </a> </span> </li> </ul> <div class="in-clipboard-label " hidden> Item in Clipboard </div> </div> </div> </header> <div class="actions-buttons inline"><div class="inner-wrap"><button class="citation-button citation-dialog-trigger" aria-label="Open dialog with citation text in different styles" data-ga-category="save_share" data-ga-action="cite" data-ga-label="open" data-all-citations-url="/22899403/citations/" data-citation-style="nlm" data-pubmed-format-link="/22899403/export/"><span class="button-label">Cite</span></button><button class="more-actions-button more-actions-dialog-trigger" title="Open dialog with more actions to take" ref="linksrc=more_actions_btn"></button><div class="display-options" data-format-key="format" data-default-format-value="abstract" data-current-format-value="abstract" role="region"><button class="trigger usa-button" title="Change format" data-ga-category="display_options" data-ga-action="display_options_dialog"><span class="button-label">Display options</span></button><div class="dropdown" hidden><div class="title"> Display options </div><div class="content"><div class="format-container"><span class="option-label"> Format </span><select name="format" data-initial-value="abstract" aria-label="Display format" id="inline-actions-display-format"><option value="abstract">Abstract</option><option value="pubmed">PubMed</option><option value="pmid">PMID</option></select></div></div></div></div></div></div> <div class="abstract" id="abstract"> <h2 class="title"> Abstract </h2> <div class="abstract-content selected" id="eng-abstract"> <p> Unlike small molecule drug products, biological products are therapeutic agents producted using of a living system or organism. Thus, the development of biologic products is a very different and complicated process that is sensitive to environmental factors such as light and temperature. Therefore, the therapeutic effect of follow-on biologic products may not be equivalent to the innovative products even though the average biosimilarity has been established. Thus, Chow et al. suggested that the assessment of biosimilarity between biologic products should be conducted on the basis of variability in 2010. In this article, we propose a biosimilar index that is derived on the basis of estimated reproducibility probability approach and Bayesian approach, respectively. We conducted simulation studies to empirically investigate the relationship of reproducibility probability under various parameter combinations. The simulation results demonstrate that the proposed method based on biosimilar index can reflect the characteristics and impact of variability on the therapeutic effect of biologic products. </p> </div> </div> <p class="copyright" id="copyright"> Copyright © 2012 John Wiley & Sons, Ltd. </p> <p class="disclaimer" id="disclaimer"> <a href="/disclaimer/" target="_blank" ga_category="literature_resources" ga_action="disclaimer_link" ga_label="under_abstract">PubMed Disclaimer</a> </p> <div class="similar-articles" id="similar"> <h2 class="title"> Similar articles </h2> <ul class="articles-list" id="similar-articles-list"> <li class="full-docsum"> <div class="docsum-content" style="display:inline;"> <a class="docsum-title" href="/22933127/" ref="article_id=22933127&linksrc=similar_articles_link&ordinalpos=1" data-ga-category="similar_article" data-ga-action="22933127" data-ga-label=""> Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics. </a> <div class="docsum-citation full-citation"> <span class="docsum-authors full-authors">Zhang N, Yang J, Chow SC, Endrenyi L, Chi E.</span> <span class="docsum-authors short-authors">Zhang N, et al.</span> <span class="docsum-journal-citation full-journal-citation">Stat Med. 2013 Feb 10;32(3):424-33. doi: 10.1002/sim.5567. 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The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics - PubMed