14:34 ET -- Biogen Inc. is one of the most talked about companies in the U.S. across all news items in the last 12 hours, according to Factiva data. The company said the U.S. Food and Drug Administration has accepted for review the abbreviated Biologics License Application for BIIB800, a proposed biosimilar to Roche Holdings AG's anti-inflammatory drug Actemra. In September, the European Medicines Agency accepted a BIIB800 Marketing Authorization Application for review. Biogen previously reported data from a Phase 3 trial demonstrating "equivalent efficacy and comparable safety and immunogenicity profile" to Actemra. Dow Jones & Co. owns Factiva. (josh.beckerman@wsj.com)

 

(END) Dow Jones Newswires

December 09, 2022 14:49 ET (19:49 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Jan 2023 to Feb 2023 Click Here for more Biogen Charts.
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Feb 2022 to Feb 2023 Click Here for more Biogen Charts.