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

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

2019年11月19日 PM07:00
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 U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTIN®i (bevacizumab). The BLA for SB8 was submitted by Samsung Bioepis in September 2019.

If approved, SB8 will be commercialized in the United States (US) by Merck & Co., Inc., Kenilworth, NJ, USA, which is known as MSD outside the US and Canada.

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 cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

i AVASTIN® is a registered trademark of Genentech Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191119005429/en/

CONTACT

MEDIA CONTACT:

Na Yun KIM

+82-31-8061-1604

nayun86.kim@samsung.com

Related Posts Plugin for WordPress, Blogger...

同じカテゴリーの記事 

  • PTSD After Wildfires Can Be Reduced with Early Triage Technology
  • Coronavirus Inactivation Reported in Recent INTERCEPT Blood System Publication in Transfusion Medicine
  • The Clinical Safety Innovator, Flat Medical, Secured Series B Financing for Global Development
  • 「プロウペス®腟用剤10mg(PROPESS®)」が日本で20年以上ぶりの子宮頸管熟化剤として承認
  •  Ferring’s Propess® is the first pharmacological treatment for cervical ripening to be approved in Japan for over 20 years