FDA

New Biosimilar Approved by the FDA

The FDA recently approved Renflexis, a biosimilar to Remicade, for the treatment of immune-disorders, including Crohn disease, ulcerative colitis, and rheumatoid arthritis. Renflexis (infliximab-abda) is administered intravenously over a period of not less than 2 hours and dosage varies according to the condition being treated.

Renflexis was approved under the FDA category for biosimilars and demonstrated no clinically meaningful differences for use, dosing regimens, strengths, dosage forms, and routes of administration from the FDA-approved biological product Remicade.
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Common adverse effects associated with Renflexis included abdominal pain, headache, pharyngitis, sinusitis, and upper respiratory infections. In addition, Renflexis might increase the risk for serious infections, including tuberculosis, bacterial sepsis, and invasive fungal infections.

The drug will be available in 6 months.

—Melissa Weiss

Reference:

Drugs@FDA: FDA approved drug products. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761054. Accessed April 24, 2017.