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.

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