Remsima extended clinical trial study result was disclosed in EULAR 2013
2013-06-16 · Celltrion · original celltrion.com ↗
RemsimaTM extended clinical trial study was disclosed in EULAR 2013 - 54-week results of RemsimaTM showed comparability with original reference product In the EULAR 2013, Celltrion disclosed extended clinical trial phase 1 & phase 3 study results through a poster session and oral presentation. According to these study result, RemsimaTM demonstrated clinical comparability to its original reference product in the week 14, week 30, and week 54 stages through all categories, including efficacy and safety profiles, and did not show any clinical difference. In particular, the clinical study revealed that between patient groups using RemsimaTM or the original product, there was no statistically significant difference in the ratio of patients who developed Anti-Drug Antibodies (ADAs). To Celltrion’s honor the PLANETAS study of RemsimaTM was invited to EULAR 2013 satelite symposium and poster session. EULAR is one of the world largest rheumatology congresses, and more than 14,000 medical doctors, health professionals, and clinical trial experts participate in EULAR and more than 1000 new study results are disclosed annually. As a representative from EULAR, Dr. Jacques-Eric Gottenberg of the Strasbourg (France) University Hospital commented “RemsimaTM proved comparability with its respective original drug in all clinical study categories” Celltrion’s satellite symposium “The Rise of Biosimilar mAbs: The New Era of Biologic Therapy in Rheumatology” which was held on June 13th was chaired by Professor Maurizio Cutolo M.D., who serves as a President-elect of the EULAR after having been appointed to this position in 2010. Professor Cutolo said that RemsimaTM is the world’s first biosimilar mAb to qualify to the strict and complex EMA biosimilar guideline. He added approval of RemsimaTM is synonymous to new alternatives costly biologic therapies. Professor Cutolo explained “Biosimilars are being highlighted as alternatives to reduce consistently increasing healthcare expenditures while balancing the growing disparity in biologic use advanced and third world nations.” He added “Celltrion’s RemsimaTM is a well-situated to provide a real alternative to solving these problems.” Temasek acquires additional KRW 150 billion worth Celltrion shares Celltrion files for approval of CT-P6, breast cancer mAb biosimilar, in Korea List Top button ABOUT US About Celltrion Notice Media Center BUSINESS Business Areas R&D Production Distribution PRODUCTS Products Pipeline ESG Environmental Social Governance ESG Archive IR Financial Information Stock Summary Public Disclosures IR Archive CAREERS Our Values How to Apply Jobs Family Site Celltrion Pharm Celltrion Skincure Celltrion Welfare Celltrion Ent. Celltrion Privacy Policy Legal Notice Export and Import Management Policy Contact Us Directions 23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea+82-32-850-5000© CELLTRION INC. ALL RIGHTS RESERVED Social Network Service LinkedIn Social Network Service Facebook Social Network Service Instagram Social Network Service Twitter $(document).ready(function() { // 게시판 공통 목록/페이징 이벤트 처리 if (document.querySelector("#listFrm") != null) { // 페이징 처리 $(document).off("click", ".pagination .click-aria").on("click", ".pagination .click-aria", function() { if (this.classList.contains("disable")) { return; } var page = this.getAttribute("value"); if (page === null || page === "") { return; } commUtil.fnSetListForm(page); }); // 검색 버튼 클릭 & Enter로 검색 $("#btnSearch").off("click").on("click", function(e) { commUtil.fnSetListForm(1); }); $("#searchWord").off("keyup").on("keyup", function(e){ if (e.key === "Enter") commUtil.fnSetListForm(1); }); } // 목록 버튼 클릭 if (document.querySelector("#btnList") != null) { $("#btnList").off("click").on("click", function(e){ commUtil.fnGoList(); }); } }); // [CSRF 공통 설정] - FORM 액션 시 CSRF Token hidden input 주입 const csrfMetaTag = document.querySelector("meta[name='csrf_token']"); if (csrfMetaTag != null) { let formList = Array.from(document.getElementsByTagName("form")); const csrfTokenValue = csrfMetaTag.getAttribute("content"); formList.forEach(form => { if (form.method.toUpperCase() != "GET") { let csrfInput = document.createElement("input"); csrfInput.setAttribute("name", "_csrf"); csrfInput.setAttribute("type", "hidden"); csrfInput.setAttribute("value", csrfTokenValue); form.appendChild(csrfInput); } }); } $(document).ready(function() { const previewOrigin = null; if (previewOrigin != null) commUtil.fnDeletePreview(previewOrigin); });
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