Inflectra FDA Approval History
Last updated by Judith Stewart, BPharm on March 2, 2021.
FDA Approved: Yes (First approved April 5, 2016)
Brand name: Inflectra
Generic name: infliximab-dyyb
Dosage form: Injection
Company: Celltrion, Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis
Inflectra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
The FDA approval of Inflectra is based on clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade.
Inflectra is administered by intravenous infusion, usually at 0, 2 and 6 weeks, then every 8 weeks depending on the condition treated.
Inflectra comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies. The most common reported side effects of Inflectra include respiratory infections, headache, coughing and stomach pain.
Development timeline for Inflectra
|Apr 5, 2016||Approval FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade|
|Feb 9, 2016||FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab|
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