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Avsola FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2020.

FDA Approved: Yes (First approved December 6, 2019)
Brand name: Avsola
Generic name: infliximab-axxq
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Avsola (infliximab-axxq) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

  • FDA approval was based on comparative analytical, nonclinical and clinical data that demonstrated Avsola to be highly similar to Remicade with no clinically meaningful differences.
  • The Avsola product label carries a Boxed Warning highlighting the increased risk of serious infections and malignancies.
  • Common side effects include upper respiratory infections, sinusitis, infusion-related reactions, headache, and abdominal pain.
  • Avsola is the fourth biosimilar to Remicade, following the approvals of Inflectra (April 2016), Renflexis (April 2017) and Ixifi (December 2017).

Development timeline for Avsola

Dec  6, 2019Approval FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade

Further information

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