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Samsung Bioepis’

US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States

US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States

バイオテクノロジーヘルスケア腫瘍学製薬　 TimeLine: First Oncology Medicine in the United States Samsung Bioepis'trastuzumab-dttb US FDA Approves ONTRUZANT

2019年01月21日

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Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the U.S. Food and Drug Administration

Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the U.S. Food and Drug Administration

バイオテクノロジーヘルスケア臨床試験製薬　 TimeLine: Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the Samsung Bioepis'

2018年09月27日

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Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

バイオテクノロジーヘルスケア腫瘍学製薬　 TimeLine: Review by the US Food and Drug Samsung Bioepis'SB3 Trastuzumab Biosimilar Candidate Accepted for

2017年12月20日

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Samsung Bioepis’ Imraldi® (Adalimumab) Recommended for Approval by European Medicines Agency

Samsung Bioepis’ Imraldi® (Adalimumab) Recommended for Approval by European Medicines Agency

バイオテクノロジーヘルスケア臨床試験製薬　 TimeLine: Recommended for Approval by European Medicines Samsung Bioepis'

2017年06月23日

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Samsung Bioepis’ Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

Samsung Bioepis’ Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

バイオテクノロジーヘルスケア糖尿病腫瘍学製薬　 TimeLine: Marketing Authorization Application for SB3 Medicines Agency Samsung Bioepis'Trastuzumab Biosimilar Candidate Accepted for

2016年10月04日

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Samsung Bioepis’ SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada

Samsung Bioepis’ SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada

バイオテクノロジーヘルスケア糖尿病腫瘍学臨床試験製薬　 TimeLine: Becomes First Etanercept Biosimilar to Receive Samsung Bioepis'

2016年09月12日

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Samsung Bioepis’ Marketing Authorization Application for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

バイオテクノロジーヘルスケア糖尿病腫瘍学臨床試験製薬　 TimeLine: Adalimumab Biosimilar Candidate Accepted for Marketing Authorization Application for SB5 Medicines Agency Samsung Bioepis'

2016年07月18日

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Samsung Bioepis’ Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration

Samsung Bioepis’ Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration

バイオテクノロジーヘルスケア糖尿病腫瘍学臨床試験製薬　 TimeLine: Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S Food and Drug Administration Samsung Bioepis'

2016年05月24日

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Samsung Bioepis’ Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union

Samsung Bioepis’ Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union

バイオテクノロジーヘルスケア臨床試験製薬　 TimeLine: Biosimilar Recommended for Approval in the Samsung Bioepis'

2016年04月02日

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Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea

Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea

バイオテクノロジーヘルスケアヘルス一般腫瘍学製薬遺伝学　 TimeLine: Infliximab Biosimilar Receives Regulatory Approval in Korea Samsung Bioepis'

2015年12月04日

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