FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate
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
KEYWORD: NEW JERSEY SOUTH KOREA UNITED STATES NORTH AMERICA ASIA PACIFIC
INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL ONCOLOGY
SOURCE: Samsung Bioepis Co., Ltd.
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PUB: 11/19/2019 05:00 AM/DISC: 11/19/2019 05:00 AM