<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title><![CDATA[삼성바이오에피스 보도자료 - 뉴스와이어]]></title><link>https://www.newswire.co.kr/?md=A10&amp;act=article&amp;no=26146></link><description><![CDATA[삼성바이오에피스 보도자료 - 뉴스와이어 RSS 서비스]]></description><lastBuildDate>Sat, 02 May 2026 13:56:30 +0900</lastBuildDate><copyright>Copyright (c) 2004~2026 Korea Newswire All rights reserved</copyright><image><url><![CDATA[https://file.newswire.co.kr/data/upfile/company_img/2019/10/12_3554238800_20191010104945_1798362597.jpg]]></url></image><language>ko-KR</language><item><title><![CDATA[Samsung Bioepis Announces US Launch of ONTRUZANT® (trastuzumab-dttb) for Early and Metastatic HER2-overexpressing Breast Cancer and Metastatic Gastric Cancer]]></title><link>https://www.newswire.co.kr/newsRead.php?no=903783</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. announced today that ONTRUZANT® (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN®[1] (trastuzumab) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the United State...]]></description><pubDate>Thu, 16 Apr 2020 09:25:41 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates]]></title><link>https://www.newswire.co.kr/newsRead.php?no=896888</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. announced today that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing LU...]]></description><pubDate>Thu, 07 Nov 2019 15:48:19 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Presents Real-world Data of BENEPALI™ (etanercept) in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress]]></title><link>https://www.newswire.co.kr/newsRead.php?no=895333</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced real-world data of BENEPALI™ in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). The results will be presented at the 2019 European Academy of Dermatology and Venereology (EADV) Congress in Madrid, Spain.[1]  BADBI...]]></description><pubDate>Thu, 10 Oct 2019 10:48:24 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical Oncology (ESMO) 2019 Congress]]></title><link>https://www.newswire.co.kr/newsRead.php?no=894742</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).[ii] The study results will be presented for the first time today at the...]]></description><pubDate>Fri, 27 Sep 2019 11:13:07 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the European Medicines Agency]]></title><link>https://www.newswire.co.kr/newsRead.php?no=836536</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab). Herceptin® is a monoclonal antibody (mAb) indicated for the treatment of early breast cancer, metastatic breast ca...]]></description><pubDate>Tue, 04 Oct 2016 11:45:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada]]></title><link>https://www.newswire.co.kr/newsRead.php?no=835280</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that BRENZYS™ - a biosimilar referencing Enbrel® (etanercept), also known as SB4 - received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. BRENZYS™ will be commercialized in Canada by Merck Canada Inc.  “As evidenced in other markets, we believe BRENZY...]]></description><pubDate>Tue, 13 Sep 2016 11:25:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; Marketing Authorization Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the European Medicines Agency]]></title><link>https://www.newswire.co.kr/newsRead.php?no=831221</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB5, a biosimilar candidate referencing Humira® (adalimumab).  SB5 is Samsung Bioepis’ third anti-TNF-α biosimilar candidate submitted for review to the EMA, following Benepali® (e...]]></description><pubDate>Mon, 18 Jul 2016 11:15:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)]]></title><link>https://www.newswire.co.kr/newsRead.php?no=828186</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate. The data will be presented through seven poster presentations and an abstract publication at the Annual European Congress on Rheumatology (EULAR 2016),...]]></description><pubDate>Thu, 09 Jun 2016 09:15:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Becomes First to Obtain European Commission Approval for Second Anti-TNF-α Biosimilar with Flixabi®]]></title><link>https://www.newswire.co.kr/newsRead.php?no=827380</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Flixabi® - a biosimilar version of Remicade® (infliximab), also known as SB2 - for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.  “With this approval, we are taking another...]]></description><pubDate>Mon, 30 May 2016 13:55:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration]]></title><link>https://www.newswire.co.kr/newsRead.php?no=826810</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade® (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic ...]]></description><pubDate>Tue, 24 May 2016 10:10:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union]]></title><link>https://www.newswire.co.kr/newsRead.php?no=822184</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi® - a biosimilar version of Remicade® (infliximab), also known as SB2 - for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spon...]]></description><pubDate>Mon, 04 Apr 2016 09:00:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Enters the European Biopharmaceutical Market with Benepali®, the First Fusion Protein Biosimilar Approved by the European Commission]]></title><link>https://www.newswire.co.kr/newsRead.php?no=815346</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Benepali® - a biosimilar referencing Enbrel® (etanercept), also known as SB4 - for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. The...]]></description><pubDate>Mon, 18 Jan 2016 09:20:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis&#039; RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea]]></title><link>https://www.newswire.co.kr/newsRead.php?no=811823</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® - a biosimilar version of Remicade® (infliximab), also known as SB2 - for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative coliti...]]></description><pubDate>Mon, 07 Dec 2015 09:30:00 +0900</pubDate></item><item><title><![CDATA[Samsung Bioepis Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union]]></title><link>https://www.newswire.co.kr/newsRead.php?no=810426</link><description><![CDATA[INCHEON, Korea--(Business Wire/Korea Newswire)--Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali® - a biosimilar version of Enbrel® (etanercept), previously known as SB4 - for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (a...]]></description><pubDate>Mon, 23 Nov 2015 10:15:00 +0900</pubDate></item></channel></rss>