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<!DOCTYPE html> <html lang="ko"> <head> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge, chrome=1"> <meta name="viewport" content="width=device-width, initial-scale=1.0, minimum-scale=1.0, maximum-scale=1.0, user-scalable=no, minimal-ui"> <meta name="format-detection" content="telephone=no"> <meta name="title" content="Celltrion" /> <meta name="author" content="Celltrion" /> <meta name="description" content="" /> <meta name="keywords" content=""> <title>Celltrion</title> <meta property="og:title" content="Celltrion"> <meta property="og:description" content=""> <meta property="og:url" content=""> <meta property="og:images" content=""> <meta property="og:type" content="website"> <link rel="shortcut icon" type="image/x-icon" href="/front/assets/common/images/common/favicon.ico"> <meta name="csrf_name" content="_csrf" /> <meta name="csrf_token" content="a17270ef-c6f9-4041-a284-20aa85ec4a60" /> <link href="/front/assets/common/js/lib/jquery-ui.min.css" 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href="/ko-kr/company/media-center" title="미디어센터">미디어센터</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="사업영역">사업영역</a> <dl> <dd> <a href="/ko-kr/business/overview" title="사업개요">사업개요</a> </dd> <dd> <a href="/ko-kr/business/rnd" title="연구개발">연구개발</a> </dd> <dd> <a href="/ko-kr/business/production" title="생산">생산</a> </dd> <dd> <a href="/ko-kr/business/distribution" title="유통">유통</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="제품정보">제품정보</a> <dl> <dd> <a href="/ko-kr/products/approved" title="허가제품">허가제품</a> </dd> <dd> <a href="/ko-kr/products/pipelines" title="파이프라인">파이프라인</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="ESG">ESG</a> <dl> <dd> <a href="/ko-kr/esg/environment" title="환경">환경</a> </dd> <dd> <a href="/ko-kr/esg/society" title="사회">사회</a> </dd> <dd> <a href="/ko-kr/esg/governance" title="지배구조">지배구조</a> </dd> <dd> <a href="/ko-kr/esg/data-room" title="ESG 자료실">ESG 자료실</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="투자">투자</a> <dl> <dd> <a href="/ko-kr/investment/financial" title="재무정보">재무정보</a> </dd> <dd> <a href="/ko-kr/investment/stock-info" title="주가정보">주가정보</a> </dd> <dd> <a href="/ko-kr/investment/notice" title="공고ㆍ공시">공고ㆍ공시</a> </dd> <dd> <a href="/ko-kr/investment/ir" title="IR 자료실">IR 자료실</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="인재채용">인재채용</a> <dl> <dd> <a href="/ko-kr/careers/talent" title="인재상">인재상</a> </dd> <dd> <a href="/ko-kr/careers/recruit" title="채용정보">채용정보</a> </dd> <dd class="outlink"> <a href="https://recruit.celltrion.com/CELLTRION.html" title="채용공고" target="_blank">채용공고</a> </dd> </dl> </li> </ul> <div class="languageWrap"> <div class="localLangSelector"> <ul> <li class="active"><a href="/ko-kr" title="KOR">KOR</a></li> <li><a href="/en-us" title="ENG">ENG</a></li> </ul> </div> <div class="globleLangSelector"> <button type="button" class="iconGlobalLanguage" title="전체 언어 선택"><span class="blind">전체 언어 선택</span></button> </div> </div> <div class="globleLangAll"> <div class="tabNavWrap language"> <ul class="tabNavList"> <li class="active"><a href="javascript:void(0);" title="Europe">Europe</a></li> <li><a href="javascript:void(0);" title="Asia Pacific">Asia Pacific</a></li> <li><a href="javascript:void(0);" title="North America">North America</a></li> <li><a href="javascript:void(0);" title="Latin America">Latin America</a></li> </ul> </div> <div class="tabContentsWrap"> <button type="button" class="iconallLanguageClose" title="닫기"><span class="blind">닫기</span></button> <div class="tabContents languageTab_01_cont_0 active"> <ul class="languageList"> <li><a href="https://celltrionhealthcare.fi/fi-fi/" target="_blank">Finland (FI)</a></li> <li><a href="https://celltrionhealthcare.fi/sv-fi/" target="_blank">Finland (SV)</a></li> <li><a href="https://www.celltrionhealthcare.fr/" target="_blank">France</a></li> <li><a href="https://www.celltrionhealthcare.de/" target="_blank">Germany</a></li> <li><a href="https://www.celltrionhealthcare.hu/" target="_blank">Hungary</a></li> <li><a href="https://www.celltrionhealthcare.ie/" target="_blank">Ireland</a></li> <li><a href="https://www.celltrionhealthcare.it/" target="_blank">Italy</a></li> <li><a href="https://www.celltrionhealthcare.nl/" target="_blank">Netherlands</a></li> <li><a href="https://www.celltrionhealthcare.com.tr/" target="_blank">Turkey</a></li> <li><a href="https://www.celltrionhealthcare.co.uk/" target="_blank">United Kingdom</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_1"> <ul class="languageList"> <li><a href="https://www.celltrion.com/ko-kr" target="_blank">Korea (HQ)</a></li> <li><a href="https://www.celltrion.com/en-us" target="_blank">Korea (EN)</a></li> <li><a href="https://www.celltrionhealthcare.jp/" target="_blank">Japan</a></li> <li><a href="https://celltrionhealthcare.com.au/" target="_blank">Australia</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_2"> <ul class="languageList"> <li><a href="https://www.celltrionhealthcare.ca/" target="_blank">Canada (EN)</a></li> <li><a href="https://www.celltrionhealthcare.ca/fr-ca/" target="_blank">Canada (FR)</a></li> <li><a href="https://www.celltrionusa.com/" target="_blank">USA</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_3"> <ul class="languageList"> <li><a href="https://www.celltrionhealthcare.com.br/" target="_blank">Brazil</a></li> <li><a href="https://celltrionhealthcare.com.co/" target="_blank">Colombia</a></li> <li><a href="https://www.celltrionhealthcare.cl/" target="_blank">Chile</a></li> <li><a href="https://celltrionhealthcare.com.pe/" target="_blank">Peru</a></li> <li><a href="https://celltrionhealthcare.mx/" target="_blank">Mexico</a></li> </ul> </div> </div> </div> </article> <div class="mobileAllMenu"> <button type="button" class="iconMobileAllMenu" title="전체메뉴"><span class="blind">전체메뉴</span></button> </div> </section> </header> <div class="cpnt_breadcrumb"> <ol> <li> <a href="/ko-kr">홈</a> </li> <li> <button type="button">제품정보</button> <ul> <li> <a href="/ko-kr/company">기업소개</a> </li> <li> <a href="/ko-kr/business">사업영역</a> </li> <li> <a href="/ko-kr/products">제품정보</a> </li> <li> <a href="/ko-kr/esg">ESG</a> </li> <li> <a href="/ko-kr/investment">투자</a> </li> <li> <a href="/ko-kr/careers">인재채용</a> </li> </ul> </li> <li> <button type="button">허가제품</button> <ul> <li> <a href="/ko-kr/products/approved">허가제품</a> </li> <li> <a href="/ko-kr/products/pipelines">파이프라인</a> </li> </ul> </li> <li> <button type="button">바이오의약품</button> <ul> <li> <a href="/ko-kr/products/approved/biologics">바이오의약품</a> </li> <li> <a href="/ko-kr/products/approved/small-molecules">케미컬의약품</a> </li> <li> <a href="/ko-kr/products/approved/news">제품소식</a> </li> </ul> </li> </ol> </div> <main id="wrapper"> <section class="product"> <article class="innerContentsWrap"> <div class="contentsWrap"> <div class="contentsHead"> <h2>허가제품</h2> </div> <div class="contentsBody"> <div class="tabNavWrap type_01" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true"> <ul class="tabNavList"> <li class="active"> <a href="/ko-kr/products/approved/biologics" title="바이오의약품">바이오의약품</a> </li> <li> <a href="/ko-kr/products/approved/small-molecules" title="케미컬의약품">케미컬의약품</a> </li> <li> <a href="/ko-kr/products/approved/news" title="제품소식">제품소식</a> </li> </ul> </div> </div> </div> </article> <article class="innerVisualWrap roundMotion"> <img src="/front/assets/common/images/product/img_sub_product_permissionBiosimilar_kv.png" alt=""> <img src="/front/assets/common/images/product/img_sub_product_permissionBiosimilar_kv_mo.png" alt=""> </article> <article class="innerContentsWrap marginclear"> <div class="contentsWrap"> <div class="contentsBody"> <div class="tabNavWrap type_02"> <ul class="tabNavList"> <li data-tab-code="ANTIBODY_BIOSIMILAR" class="active"> <a href="javascript:void(0);" title="바이오시밀러">바이오시밀러</a> </li> <li data-tab-code="ANTIBODY_NEW_DRUG"> <a href="javascript:void(0);" title="바이오 신약">바이오 신약</a> </li> </ul> </div> <div class="tabContentsWrap"> <div class="tabContents tab_02_cont_0 active"> <div class="cpnt_product_table"> <h3 class="heading ghidden"><span>바이오시밀러</span></h3> <div class="cpnt_divtable t-cell5"> <div class="thead isPc" aria-hidden="ture"> <b>제품명</b> <b>제품 이미지</b> <b>성분명</b> <b>적응증</b> <b>허가기관</b> </div> <dl class="tbody"> <div> <dt><b class="ghidden">제품명</b><span>Remsima®<br />램시마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715141217-6b08bf38-1631-45d9-8d23-d2fa837f7142.png" alt="류마티스 관절염, 염증성 장질환"> </dd> <dd><b class="ghidden">성분명</b><span>Infliximab</span></dd> <dd><b class="ghidden">적응증</b><span>류마티스 관절염, 염증성 장질환 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/remsima"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125544"><span>FDA(미국)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=201206204aupdateTs2023-02-06%2013:45:23.387226b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Herzuma®<br />허쥬마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715121256-005fd86a-93a1-4152-80b0-5b231841b85c.png" alt="전이성 유방암, 전이성 위암"> </dd> <dd><b class="ghidden">성분명</b><span>Trastuzumab</span></dd> <dd><b class="ghidden">적응증</b><span>유방암, 전이성 위암 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761091"><span>FDA(미국)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=201400159aupdateTs2023-09-14%2019:00:00.0b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Truxima®<br />트룩시마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715111240-dcbbff17-2bec-4af0-8491-225cdb97eaef.png" alt="비호지킨 림프종"> </dd> <dd><b class="ghidden">성분명</b><span>Rituximab</span></dd> <dd><b class="ghidden">적응증</b><span>비호지킨 림프종, 만성 림프구성 백혈병 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/truxima"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761088"><span>FDA(미국)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=201504895aupdateTs2023-11-29%2017:05:04.533233b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Remsima® SC<br />램시마®SC</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715101201-ba559559-f683-45b5-80ad-5e6146113068.png" alt="류마티스 관절염, 염증성 장질환"> </dd> <dd><b class="ghidden">성분명</b><span>Infliximab</span></dd> <dd><b class="ghidden">적응증</b><span>류마티스 관절염, 염증성 장질환 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/remsima"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202200974aupdateTs2023-04-27%2010:35:48.244721b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Yuflyma®<br />유플라이마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715061220-7320e397-08d7-415e-9002-82768467b95a.png" alt="류마티스 관절염, 염증성 장질환"> </dd> <dd><b class="ghidden">성분명</b><span>Adalimumab</span></dd> <dd><b class="ghidden">적응증</b><span>류마티스 관절염, 염증성 장질환 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=761219"><span>FDA(미국)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202106947aupdateTs2023-07-03%2017:55:00.0b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Vegzelma®<br />베그젤마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715051204-9b37116d-bea1-4961-b4b0-7041ea7f5e68.png" alt="전이성 직결장암, 비소세포폐암"> </dd> <dd><b class="ghidden">성분명</b><span>Bevacizumab</span></dd> <dd><b class="ghidden">적응증</b><span>전이성 직결장암, 비소세포폐암 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=761268"><span>FDA(미국)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202203696aupdateTs2023-07-10%2009:44:02.874135b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Eydenzelt®<br />아이덴젤트®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/241808290715-d58a0b17-d864-41cf-b893-9de1997f400f.jpg" alt="당뇨병성 황반부종, 황반변성 치료제"> </dd> <dd><b class="ghidden">성분명</b><span>Aflibercept</span></dd> <dd><b class="ghidden">적응증</b><span>당뇨병성 황반부종, 황반변성 치료제</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202401327aupdateTs2024-06-19%2016:23:00.054976b"><span>MFDS(한국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Steqeyma®<br />스테키마®</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/241808290730-244bc83e-c469-4b08-b008-1e95422f8ed9.jpg" alt="건선, 염증성 장질환 등"> </dd> <dd><b class="ghidden">성분명</b><span>Ustekinumab</span></dd> <dd><b class="ghidden">적응증</b><span>건선, 염증성 장질환 등</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202401434aupdateTs2024-07-03%2008:13:29.920365b"><span>MFDS(한국)</span></a> </dd> </div> </dl> </div> <div class="cpnt_subscript"> <p class="referenceMark">본 사이트에서 제공하는 제품 정보는 의료 정보용으로만 사용되며 홍보 또는 판매를 목적으로 하지 않습니다. 의약품 관련 자세한 사항은 의사 또는 의료 전문가에게 문의하십시오.</p> </div> </div> </div> <div class="tabContents tab_02_cont_1"> <div class="cpnt_product_table"> <h3 class="heading ghidden"><span>바이오 신약</span></h3> <div class="cpnt_divtable t-cell5"> <div class="thead isPc" aria-hidden="ture"> <b>제품명</b> <b>제품 이미지</b> <b>성분명</b> <b>적응증</b> <b>허가기관</b> </div> <dl class="tbody"> <div> <dt><b class="ghidden">제품명</b><span>Zymfentra™<br />짐펜트라™</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715031239-cecae2d5-5ff8-4759-b75c-33a2693f3983.png" alt="염증성 장질환"> </dd> <dd><b class="ghidden">성분명</b><span>Infliximab</span></dd> <dd><b class="ghidden">적응증</b><span>염증성 장질환</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=761358"><span>FDA(미국)</span></a> </dd> </div> <div> <dt><b class="ghidden">제품명</b><span>Regkirona™<br />렉키로나™</span></dt> <dd class="img"> <img src="https://cellhomeblob.blob.core.windows.net/files/permission/232715011220-5a604176-1ec4-4287-8f8c-3f286882dd16.png" alt="코로나바이러스감염증-19"> </dd> <dd><b class="ghidden">성분명</b><span>Regdanvimab</span></dd> <dd><b class="ghidden">적응증</b><span>코로나바이러스감염증-19</span></dd> <dd><b class="ghidden">허가기관</b> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona"><span>EMA(유럽)</span></a> <a class="btn_gconfirm" title="확인후 사이트이동합니다" href="https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202101124aupdateTs2023-10-27%2017:28:31.308483b"><span>MFDS(한국)</span></a> </dd> </div> </dl> </div> <div class="cpnt_subscript"> <p class="referenceMark">본 사이트에서 제공하는 제품 정보는 의료 정보용으로만 사용되며 홍보 또는 판매를 목적으로 하지 않습니다. 의약품 관련 자세한 사항은 의사 또는 의료 전문가에게 문의하십시오.</p> </div> </div> </div> </div> </div> </div> </article> </section> </main> <footer id="footer"> <section class="innerWrap"> <div class="footerTopBtn"> <button type="button" class="iconGoToTop" title="위로 이동"><span class="blind">위로 이동</span></button> </div> <article id="footerWrap"> <ul class="menu"> <li> <dl> <dt> <a href="javascript:void(0);" title="기업소개">기업소개</a> </dt> <dd> <a href="/ko-kr/company/celltrion" title="기업개요">기업개요</a> </dd> <dd> <a href="/ko-kr/company/notice" title="공지사항">공지사항</a> </dd> <dd> <a 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