Second FDA-Approved Tocilizumab Biosimilar Has Intravenous, Subcutaneous Formulations

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167227</fileName> <TBEID>0C04EF24.SIG</TBEID> <TBUniqueIdentifier>MD_0C04EF24</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240308T124226</QCDate> <firstPublished>20240308T130450</firstPublished> <LastPublished>20240308T130450</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240308T130450</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Lucy Hicks</byline> <bylineText>LUCY HICKS</bylineText> <bylineFull>LUCY HICKS</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, announced on March 7.T</metaDescription> <articlePDF/> <teaserImage>174399</teaserImage> <teaser>It’s unclear when the new tocilizumab products will be commercially available.</teaser> <title>Second FDA-Approved Tocilizumab Biosimilar Has Intravenous, Subcutaneous Formulations</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">26</term> <term>25</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> </sections> <topics> <term canonical="true">289</term> <term>241</term> <term>271</term> <term>285</term> <term>252</term> <term>290</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24006772.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">Wikimedia Commons/FitzColinGerald/Creative Commons License</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Second FDA-Approved Tocilizumab Biosimilar Has Intravenous, Subcutaneous Formulations</title> <deck/> </itemMeta> <itemContent> <p><br/><br/>The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, <span class="Hyperlink"><a href="https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes">announced on March 7</a></span>.<br/><br/>This is the second <span class="Hyperlink">tocilizumab</span> biosimilar approved by the regulatory agency and the first to be approved in both intravenous (IV) and subcutaneous formulations that are available with the reference product, Actemra, the company said in a press release. <br/><br/>[[{"fid":"174399","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"FDA icon","field_file_image_credit[und][0][value]":"Wikimedia Commons/FitzColinGerald/Creative Commons License","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Tocilizumab-aazg is an interleukin-6 (IL-6) receptor antagonist indicated for:</p> <ul class="body"> <li>Adults with moderate to severe <span class="Hyperlink">rheumatoid arthritis</span> who have had an inadequate response to one or more disease-modifying antirheumatic drugs</li> <li>Adults with <span class="Hyperlink">giant cell arteritis</span></li> <li>Patients aged 2 years or older with active polyarticular <span class="Hyperlink">juvenile idiopathic arthritis</span></li> <li>Patients aged 2 years or older with active systemic juvenile idiopathic arthritis</li> </ul> <p>“Fresenius Kabi is leading the way as the first company to receive FDA approval for both IV and subcutaneous formulations of its tocilizumab biosimilar and is available in prefilled syringe, pen injector, and vial presentations,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi Biopharma, said in a statement.<br/><br/>The FDA approved the <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/996973">first tocilizumab biosimilar</a></span>, manufactured by Biogen, in late September 2023. It is administered by IV infusion.<br/><br/>Tocilizumab-aazg’s approval was based on outcome and safety data from a dozen clinical studies. The drug can be administered via intravenous formulation (20 mg/mL) or subcutaneously via a single-dose 162-mg/0.9-mL prefilled syringe or single-dose prefilled autoinjector. <br/><br/>The most common side effects for tocilizumab-aazg include upper respiratory tract infections, <span class="Hyperlink">headache</span>, <span class="Hyperlink">hypertension</span>, and injection site reactions. The most serious side effects include serious infections, perforation of the stomach or intestines, hepatotoxicity, and changes in certain lab results.<br/><br/>Tocilizumab-aazg has already launched in 10 countries, Fresenius Kabi shared in the press release, and plans to launch in additional countries in 2024 and 2025. It is not clear when tocilizumab-aazg will be made available in the United States.<br/><br/>“In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the United States commencing on the license dates, which are confidential,” the company noted.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-second-tocilizumab-biosimilar-2024a10004fh?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>