FDA Approves Avsola, Fourth Biosimilar Infliximab

December 9, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved the tumor necrosis factor blocker Avsola (infliximab-axxq; Amgen), a biosimilar to Remicade (infliximab; Janssen Biotech, Inc.).

Avsola is the fourth biosimilar to Remicade. Inflectra (infliximab-dyyb; Celltrion, Inc.) was approved in April 2016; Renflexis (infliximab-abda; Samsung Bioepis Co., Ltd.) was approved in April 2017; and Ixifi (infliximab-qbtx; Pfizer Inc.) was approved in December 2017.

Avsola is administered by intravenous infusion. It is approved for all eligible indications of the reference product, including:

  • Adult patients and pediatric patients (6 years of age and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
  • Adult and pediatric patients (6 years of age and older) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
  • Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.
  • Patients with active ankylosing spondylitis (arthritis of the spine).
  • Patients with active psoriatic arthritis.
  • Adult patients with chronic severe plaque psoriasis.

Detailed information about the approved uses is provided in the full prescribing information. Avsola is not approved as an interchangeable product.