医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

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

2017年12月20日 AM11:13
このエントリーをはてなブックマークに追加


 

INCHEON, Korea

Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171219006354/en/

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

i Herceptin® is a registered trademark of Genentech Inc.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171219006354/en/

CONTACT

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • ティルレイが国際諮問委員会の設立を発表
  • Celltrion and Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications
  • Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD
  • Tilray®宣布成立国际顾问委员会
  • 武田和纽约科学院宣布2019年度科学创新者奖获奖人