삼성바이오에피스 보도자료
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada
09월 13일 11:25
Samsung Bioepis Co., Ltd. today announced that BRENZYS™ - a biosimilar referencing Enbrel® (etanercept), also known as SB4 - received regulatory approval in Canada f...
Samsung Bioepis' Marketing Authorization Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the European Medicines Agency
07월 18일 11:15
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) fo...
Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)
06월 09일 09:15
Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investi...
Samsung Bioepis Becomes First to Obtain European Commission Approval for Second Anti-TNF-α Biosimilar with Flixabi®
05월 30일 13:55
Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Flixabi® - a biosimilar version of Remicade® (infliximab), also known as SB2 - f...
Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration
05월 24일 10:10
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) ...
Samsung Bioepis' Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union
04월 04일 09:00
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 opi...
Samsung Bioepis Enters the European Biopharmaceutical Market with Benepali®, the First Fusion Protein Biosimilar Approved by the European Commission
01월 18일 09:20
Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Benepali® - a biosimilar referencing Enbrel® (etanercept), also known as SB4 - f...
Samsung Bioepis' RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
2015년 12월 07일
Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® - a biosimilar version of Remicade® (inflixima...
Samsung Bioepis Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union
2015년 11월 23일
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 opi...
삼성바이오에피스
상장여부 : 비상장
본사 소재지 : 인천
업종: 건강-제약
웹사이트: http://www.samsungbioepis.com
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