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