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<div class="tools"> <div class="form-section"> <button aria-label="search form toggle" id="btn-search"><i class="fa fa-search"></i></button> <div class="form-holder"> <form role="search" method="get" class="search-form" action="https://blog.covance.com/"> <label> <span class="screen-reader-text">Search for:</span> <input type="search" class="search-field" placeholder="Search …" value="" name="s" /> </label> <input type="submit" class="search-submit" value="Search" /> </form> </div> </div> </div> <ul class="social-networks"> <li><a href="https://www.linkedin.com/company/covancebylabcorp" target="_blank" rel="nofollow"><i class="fab fa-linkedin"></i></a></li> <li><a href="https://twitter.com/covance" target="_blank" rel="nofollow"><i class="fab fa-twitter-square"></i></a></li> <li><a href="https://www.facebook.com/CovanceByLabcorp" target="_blank" rel="nofollow"><i class="fab fa-facebook"></i></a></li> <li><a href="http://www.youtube.com/user/CovanceMedia" target="_blank" rel="nofollow"><i class="fab fa-youtube"></i></a></li> </ul> </div> </div> </div> </header> <div class="top-bar"> <div class="container"> <header class="page-header"> <h1 class="page-title"><span class="vcard">Alicia M. Baker</span></h1><div class="archive-description"><p>Alicia M. Baker, Director, Global Regulatory Affairs Strategy, Covance</p> </div> </header><!-- .page-header --> <div class="breadcrumb-wrapper"> <div id="crumbs" itemscope itemtype="http://schema.org/BreadcrumbList"> <span itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"> <a itemprop="item" href="https://blog.covance.com"><span itemprop="name">Home</span></a> <meta itemprop="position" content="1" /> <span class="separator">/</span> </span><span class="current" itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"><a itemprop="item" href="https://blog.covance.com/author/aliciambaker/"><span itemprop="name">Alicia M. Baker</span></a><meta itemprop="position" content="2" /></span></div></div><!-- .breadcrumb-wrapper --> </div> </div> <div class="container main-content"> <div id="content" class="site-content"> <div class="row"> <div id="primary" class="content-area"> <main id="main" class="site-main"> <div class="row"> <article id="post-3143" class="post-3143 post type-post status-publish format-standard has-post-thumbnail hentry category-data-informatics category-drug-development category-patient-recruitment category-phase-iib-iii tag-arthritis tag-biosimilars tag-fda latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" class="post-thumbnail"><img width="300" height="300" src="https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="Rheumatoid Arthritis Biosimilars" srcset="https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1.jpg 335w, https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1-150x150.jpg 150w, https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1-300x300.jpg 300w" sizes="(max-width: 300px) 100vw, 300px" data-attachment-id="3146" data-permalink="https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/ra-hand-2/" data-orig-file="https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1.jpg" data-orig-size="335,335" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="RA-Hand" data-image-description="<p>Rheumatoid Arthritis Biosimilars</p> " data-medium-file="https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1-300x300.jpg" data-large-file="https://blog.covance.com/wp-content/uploads/2017/05/RA-Hand-1.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/&title=Rheumatoid%20Arthritis%20Biosimilars:%20Regulatory%20and%20Clinical%20Considerations" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Rheumatoid%20Arthritis%20Biosimilars:%20Regulatory%20and%20Clinical%20Considerations https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="mailto:?Subject=Rheumatoid%20Arthritis%20Biosimilars:%20Regulatory%20and%20Clinical%20Considerations&Body=https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" rel="nofollow" target="_blank"><i class="fa fa-envelope" aria-hidden="true"></i></a></li> </ul> </div> </div> </div><h2 class="entry-title" itemprop="headline"><a href="https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" rel="bookmark">Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations</a></h2><div class="entry-meta"><span class="byline" itemprop="author" itemscope itemtype="https://schema.org/Person"> by <span class="author vcard" itemprop="name"><a class="url fn n" href="https://blog.covance.com/author/aliciambaker/">Alicia M. Baker</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://blog.covance.com/2017/06/rheumatoid-arthritis-biosimilars-regulatory-clinical-considerations/" rel="bookmark"><time class="entry-date published updated" datetime="2020-02-17T23:08:47-05:00" itemprop="dateModified">Monday, February 17, 2020</time><time class="updated" datetime="2017-06-06T08:55:27-04:00" itemprop="datePublished">Tuesday, June 6, 2017</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-3143 --> </div> <div class="pagination"></div> </main><!-- #main --> </div><!-- #primary --> </div><!-- .row/not-found --> </div><!-- #content --> </div><!-- .container/.main-content --> <footer id="colophon" class="site-footer" itemscope itemtype="http://schema.org/WPFooter"> <div class="site-info"> <div class="container"> <span class="copyright">Copyright © 2020 Covance Inc. 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