www.fdanews.com/articles/195210-amgen-gets-fda-approval-for-remicade-biosimilar-avsola
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Amgen gets FDA approval for Remicade Biosimilar Avsola
December 19, 2019
The FDA approved Amgen’s Avsola (infliximab-axxq) as a biosimilar for Janssen’s Remicade (infliximab).
The approval was based on the results of a clinical study in which Avsola was shown to be highly similar to Remicade with no clinically meaningful differences.
Avsola is approved for all Remicade indications, which includes moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's Disease in adults and children, and ankylosing spondylitis.