Trending: Biogen Application for Actemra Biosimilar Accepted for Review
December 09 2022 - 3:04PM
Dow Jones News
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)
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