FDA Approves Avsola, Fourth Biosimilar Infliximab
December 9, 2019
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.