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FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

November 19, 2019

INCHEON, Korea--(BUSINESS WIRE)--Nov 19, 2019--

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

KEYWORD: NEW JERSEY SOUTH KOREA UNITED STATES NORTH AMERICA ASIA PACIFIC

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL ONCOLOGY

SOURCE: Samsung Bioepis Co., Ltd.

Copyright Business Wire 2019.

PUB: 11/19/2019 05:00 AM/DISC: 11/19/2019 05:00 AM

http://www.businesswire.com/news/home/20191119005429/en