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 

  • サラダックス・バイオメディカル、サルバトーレ・J・サラモネ博士が権威ある C.E. Pippenger博士賞を受賞したと発表
  • Japan’s MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer
  • VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan
  • TAE Life Sciences Announces Installation of First Accelerator-based Neutron Beam System for Biologically Targeted Radiation Therapy at Xiamen Humanity Hospital in China
  • New Study Evaluates the Feasibility of Using Masimo EMMA® Capnography on Mechanically Ventilated Neonates