CINXE.COM

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id="block-block-26" class="block block-block"> <div class="content"> <div class="container_12"><a href="https://www.bio-techne.com/account/novus-bio-techne/login?_ga=2.17257593.151271452<br />
5.1724696046-473375462.1712005244" style="margin: 0 10px;" target="_blank"><img alt="Novus Biologicals products are now on bio-techne.com" src="https://images.novusbio.com/design/ready-to-buy-novus-products-login.png" style="height:120px; width:940px" /></a></div> </div> </div> </div> <div class="main grid_11" itemscope itemtype="http://schema.org/Blog"> <h1 itemprop="name">Unlocking the Potential of Biosimilars in Immuno-Oncology</h1> <div itemprop="dateCreated" content="20231016">Mon, 10/16/2023 - 09:31</div><br /><br /> <div itemprop="text"> <div class="region region-content"> <div id="block-et-messages-et-messages-block" class="block block-et-messages"> <div class="content"> <span></span> </div> </div> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-67871941" class="node node-article node-promoted clearfix"> <div class="content"> <div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><table width="100%" border="0" cellpadding="0"> <tbody> <tr align="left"> <td><em><img src="https://images.novusbio.com/design/nb-blog-biosimilars-in-io-banner.jpg" alt="Purple and blue antibodies with clear glass vial in the middle on a purple-blue background." width="600" height="150" title="Antibodies and glass vials , banner." border="0"></em></td> </tr> </tbody> </table> <p><strong>By Jennifer Jones, M.S.</strong></p> <h2>Biosimilar Antibodies: Imitation Meets Innovation</h2> <p>In the ever-evolving medical landscape, a new class of pharmaceuticals is emerging as a game-changer, poised to transform the way we approach treatment options: <a href="https://www.bio-techne.com/reagents/antibodies/biosimilar-antibodies" target="_blank">Biosimilars</a>. Biosimilars are biologics, such as antibodies and proteins, that demonstrate therapeutic equivalency to the original approved drug, also known as the reference product. The <a href="https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars" target="_blank">Food and Drug Administration (FDA)</a> defines a biosimilar as having “no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness) from an existing FDA-approved biologics”.<sup>1</sup> Moreover, they are equivalent to the therapeutic drug in terms of functionality, pharmacokinetics, and immunogenicity.<sup>2</sup> As of September 2023, the FDA has approved 43 biosimilars that are categorized into four types of biologics, including monoclonal antibodies (mAbs).<sup>1,3</sup> Examples of FDA-approved monoclonal biosimilar antibodies, their target molecule, and therapeutic area are listed in Table 1.</p> <h3>Table 1. Examples of Biosimilar Antibodies and Their Therapeutic Areas <sup>1,3</sup></h3> <table cellpadding="6" cellspacing="6" style="margin-left:auto; margin-right:auto; width:650px" class="alternate blueTop center lightPad withGrid"> <tr bgcolor="#005F9E"> <td width="25%" align="center" valign="middle"> <span style="color: #FFFFFF; font-weight: bold;">Biosimilar </span> </td> <td width="25%" align="center" valign="middle"> <span style="color: #FFFFFF; font-weight: bold;">Target Molecule </span> </td> <td width="25%" align="center" valign="middle"> <span style="color: #FFFFFF; font-weight: bold;">Therapeutic Areas </span> </td> </tr> <tr valign="top"> <td width="25%" align="center" valign="middle"> <p><b><a href="/search?keywords=Adalimumab&common_name=TNF-alpha">Adalimumab</a></b></p> </td> <td width="25%" align="center" valign="middle"> <p>TNF-alpha</p> </td> <td width="25%" align="left" valign="middle"> <p>Chron’s disease, Psoriasis, Psoriatic arthritis, Rheumatoid arthritis (RA), Ulcerative colitis</p> </td> </tr> <tr valign="top"> <td width="25%" align="center" valign="middle"> <p><strong><a href="/search?keywords=Bevacizumab&common_name=VEGF">Bevacizumab</a></strong></p> </td> <td width="25%" align="center" valign="middle"> <p>VEGF</p> </td> <td width="25%" align="left" valign="middle"> <p>Colorectal cancer, Non-small cell lung cancer (NSCLC), Renal cell carcinoma</p> </td> </tr> <tr valign="top"> <td width="25%" align="center" valign="middle"> <p><strong><a href="/search?keywords=Rituximab&common_name=CD20">Rituximab</a></strong></p> </td> <td width="25%" align="center" valign="middle"> <p>CD20</p></td> <td width="25%" align="left" valign="middle"> <p>Chronic lymphocytic leukemia (CLL), Non-Hodgkin’s lymphoma (NHL), Rheumatoid arthritis (RA)</p> </td> </tr> <tr valign="top"> <td width="25%" align="center" valign="middle"> <p><strong><a href="/search?keywords=Trastuzumab&common_name=ErbB2/Her2">Trastuzumab</a></strong></p> </td> <td width="25%" align="center" valign="middle"> <p>ErbB2/Her2</p> </td> <td width="25%" align="left" valign="middle"> <p>Breast Cancer</p> </td> </tr> </table> <p align="center"> </p> <p align="center"><a href="https://www.bio-techne.com/reagents/antibodies/biosimilar-antibodies" class="link_button" target="_blank">Learn More About Bio-Techne Biosimilar Antibodies</a></p> </br> <h2>The Role of Biosimilar Antibodies in Targeted Cancer Therapy</h2> <p>Direct tumor elimination is the common goal of many <a href="https://www.bio-techne.com/research-areas/immuno-oncology" target="_blank">cancer immunotherapy</a> mAbs. Developed to target both solid tumors and hematological cancers, these mAbs function to: </p> <ul><li>Block receptor-ligand binding</li></ul> <ul><li>Induce cell lysis</li></ul> <ul><li>Tag tumor cells for opsonization<sup>4</sup></li></ul> </p> <p>Biosimilars in this context are valuable counterparts to the original therapeutic antibodies, providing equivalent effectiveness in targeting tumors and enhancing immune responses. They are crucial players in the quest for more effective and accessible treatment options.</p> <p>One such group of ligand-blocking biosimilars target members of the EGFR family, including <a href="/primary-antibodies/erbb2-her2">ErbB2/Her2</a>.<sup>5,6</sup> Her2 is overexpressed in almost 30% of breast cancer cases, making it a prime target for biosimilar antibodies like Trastuzumab, which works by blocking ligand binding and disrupting receptor function by preventing Her2 homodimerization. </p> <p> </p> <p align="left"><img src="https://images.novusbio.com/design/nb-blog-biosimilars-in-io-erbb2-her2-block-neutralize-mab9589.jpg" alt="Neutralization assay shows that ErbB2/Her2 (Trastuzumab Biosimilar) Antibody inhibits SK-BR-3 human breast cancer cell line proliferation as depicted by the plot of Mean RFU vs. antibody concentration." width="350" height="264" style="padding-right:20px; padding-bottom:10px;" title="ErbB2/Her2 (Trastuzumab Biosimilar) Antibody inhibits cancer cell line proliferation in a dose-dependent manner." align="left"></p> <p align="left"> </p> <p><em><strong>Cancer Cell Proliferation Inhibition by ErbB2/Her2 (Trastuzumab Biosimilar) Antibody.</strong> Neutralization assay showing inhibition of SK-BR-3 human breast cancer cell line proliferation by Human Anti-Human ErbB2/Her2 (Research Grade Trastuzumab Biosimilar) Monoclonal Antibody (Catalog # <a href="/products/erbb2-her2-antibody-hu5_mab9589">MAB9589</a>) as measured by Resazurin (R&D Systems Catalog # <a href="https://www.bio-techne.com/p/activity-assays/resazurin_ar002" target="_blank">AR002</a>). The median effective dose for this effect is typically 15-75 ng/mL.</em></p> <p> </p> <p> </p> <p> </p> <p>Biosimilar mAbs also target hematopoietic differentiation antigens like <a href="/primary-antibodies/cd30-tnfrsf8">CD30/TNFRSF8</a>, <a href="/primary-antibodies/cd52">CD52</a>, and <a href="/primary-antibodies/cd20">CD20</a>. For example, Rituximab targets CD20, a B-cell maturation marker, and is used to treat non-Hodgkin’s lymphoma (NHL) and other hematological cancers. Rituximab-bound B-cells are eliminated by cell lysis engaging the Fc region of the antibody and FcγR receptors on immune cells. This activation leads to the release of pro-inflammatory compounds and the demise of targeted tumor cells.</p> <p><u><strong>Immune-checkpoint Inhibitors</strong></u><p> <p>Another breakthrough approach for anti-cancer mAb-based therapy targets a special class of proteins called <a href="https://www.bio-techne.com/reagents/proteins/immune-checkpoint-proteins" target="_blank">immune-checkpoint proteins</a>. Immune checkpoint proteins, such as <a href="/primary-antibodies/ctla-4">CTLA-4</a> and <a href="/primary-antibodies/pd-1">PD-1</a>,<sup>6</sup> are critical mediators of any immune response. Immune checkpoint inhibitor mAbs target these proteins and function to boost the body's immune response against cancer. One of the most well studied immune checkpoints is the PD-1/<a href="/primary-antibodies/pd-l1">PD-L1</a> receptor-ligand interaction. PD-1 is expressed on the surface of T cells and functions to inhibit T cell activation, while PD-L1 is often overexpressed on target tumor cells. The anti-PD-1 and anti-PD-L1 antibodies Nivolumab (Opdivo®) and Atezolizumab (Tencentriq®), respectively, are inhibitors that work to restore T cell function and counteract this negative regulation. To further investigate this important immune checkpoint, Bio-Techne recently added <a href="https://www.bio-techne.com/search?keywords=Pembrolizumab" target="_blank">Pembrolizumab</a> (anti-PD-1) to our biosimilar antibody portfolio.</p> <p> </p> <p> </p> <p align="center"><img src="https://images.novusbio.com/design/nb-blog-biosimilars-in-io-pdl1-flow-cytometry-mab10348.jpg" alt="Flow cytometry analysis showing PD-L1 (Atezolizumab) Antibody is detected in MDA-MB-231 human breast cancer cell line following staining (orange, filled histogram), but irrelevant antibody is not (open histogram)." width="350" height="351" style="padding-right:20px; padding-bottom:10px;" title="Detection of PD-L1 (Atezolizumab) Antibody in human breast cancer cell line, flow cytometry." align="center"><br> <strong><em>Flow Cytometry Analysis Showing Detection of PD-L1/B7-H1 antibody in MDA-MB-231 human breast adenocarcinoma cell line.</em></strong><em>MDA-MB-231 human breast adenocarcinoma cell line was stained with Human Anti-Human PD-L1/B7-H1 (Atezolizumab Biosimilar) Monoclonal Antibody (Catalog # <a href="/products/pd-l1-antibody-hu124_mab10348">MAB10348</a>, filled histogram) or irrelevant antibody (open histogram) followed by APC-conjugated Goat Anti-Human IgG Secondary Antibody (Catalog # <a href="/products/igg-antibody_f0135">F0135</a>).</em></p> <br> <p align="center"><a href="https://www.bio-techne.com/resources/literature/immune-checkpoint-targets-for-cancer-immunotherapy-research-poster" class="link_button" target="_blank">Request Bio-Techne’s Immune Checkpoint Poster</a></p> <p align="center"> </p> <h2>Conclusions and the Future of Biosimilars in the Fight Against Cancer</h2> <p>Biosimilar antibodies are becoming crucial tools in the fight against cancer, offering new hope for patients battling this deadly disease. These biologically equivalent counterparts not only expand access to cutting-edge therapies but also offer cost-effective solutions that can revolutionize healthcare. As research continues to advance, we can anticipate an even brighter outlook for biosimilar antibodies and more innovative treatments on the horizon.</p> <p> </p> <p><img src="https://images.novusbio.com/design/jen-jones-headshot-image-headshot.jpg" alt="Jennifer Jones" style="float:left; height:50px; padding-right:15px; width:50px" title="Jennifer Jones" /><a href="https://www.linkedin.com/in/jenniferjones87/" target="_blank">Jennifer Jones, M.S.</a><br> Product Marketing Specialist at Novus Biologicals LLC</p> <p> </p> <p><strong>References</strong><br> </p> <ol> <li>Center for Drug Evaluation and Research. <em>Biosimilars</em>. U.S. Food and Drug Administration. <a href="https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars" target="_blank">https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars</a> </li> <li>Nabhan C, Parsad S, Mato AR, Feinberg BA. <a href="https://jamanetwork.com/journals/jamaoncology/article-abstract/2644654" target="_blank">Biosimilars in Oncology in the United States: A Review</a> [published correction appears in JAMA Oncol. 2017 Oct 1;3(10):1431]. <em>JAMA Oncol</em>. 2018;4(2):241-247. doi:10.1001/jamaoncol.2017.2004</li> <li>Generics and Biosimilars Initiative. <em>Biosimilars approved in the US</em>. GaBi Online. (Last Updated: 2023, May 19). <a href="https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us" target="_blank">https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us </a> </li> <li>Liu J, Pandya P, Afshar S. <a href="https://www.mdpi.com/1422-0067/22/4/2008" target="_blank">Therapeutic Advances in Oncology</a>. <em>Int J Mol Sci</em>. 2021;22(4):2008. Published 2021 Feb 18. doi:10.3390/ijms22042008 </li> <li>Weiner LM, Surana R, Wang S. <a href="https://www.nature.com/articles/nri2744" target="_blank">Monoclonal antibodies: versatile platforms for cancer immunotherapy</a>. <em>Nat Rev Immunol. </em>2010;10(5):317-327. doi:10.1038/nri2744 </li> <li>Scott AM, Allison JP, Wolchok JD. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380347/" target="_blank">Monoclonal antibodies in cancer therapy</a>. <em>Cancer Immun</em>. 2012;12:14.</li> </ol> <p><style> .sprite_newWindow { background: url(//images.novusbio.com/design/dataSheetSprite12-09-14.png) -52px -3px no-repeat; width: 16px; height: 16px; display: inline-block; *display: inline; } </style> </p> </div></div></div><div class="field field-name-field-tags field-type-taxonomy-term-reference field-label-above"><div class="field-label">Tags: </div><div class="field-items"><div class="field-item even"><a href="/antibody-news/tags/biosimilar">Biosimilar</a></div><div 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