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What is the difference between Renflexis and Remicade?

Answers (1)

Official Answer by 5 Jul 2017

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker from Samsung Bioepis that is biosimilar to Remicade (infliximab), from Janssen Biotech. According to the FDA, a biosimilar must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product -- in this case Remicade.

Only minor differences in clinically inactive components are allowable in biosimilar products. Renflexis is given as an intravenous infusion similar to Remicade, and is indicated for the same indications, specifically treatment of Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The first biosimilar to Remicade, Pfizer’s Inflectra (infliximab-dyyb) was approved by the FDA in April, 2016.

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