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Inflectra Approval History

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 was based on clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade.

Inflectra is administered by intravenous infusion, usually every two weeks for the first six weeks, then every 6-8 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 History and FDA Approval Process for Inflectra

DateArticle
Apr  5, 2016Approval FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade
Feb  9, 2016FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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