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Saturday, December 10, 2022 12:23:55 AM
It appears the Biosimilar drug market is expanding. Saw this today about Biogen:
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 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.
More here about the FDA and Biosimilars: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
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