FDA Approves Renflexis, Second Biosimilar for Remicade

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On April 21st, the FDA approved Renflexis (infliximab-abda), the second biosimilar to the popular medication Remicade, (infliximab) indicated for immune disorders.

A biosimilar is like a generic medication in that it is less expensive than the brand name medication. However, the difference is that biosimilars are made out living cells, so they may be slightly different from their counterpart. This usually means that the pharmacist will not substitute these medications without approval from a doctor. For more information on what a biosimilar is, read our previous blog post here.

What is Renflexis indicated for?
Renflexis is indicated for multiple conditions including crohn’s disease, pediatric crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

How is Renflexis to be used?
Renflexis will be available as an intravenous infusion in a strength of 100mg/20ml. Your dose of Renflexis will be determined by your doctor based on your weight and your specific condition. It is to be administered by your doctor at his or her office as an intravenous infusion over a period of no less than 2 hours.

Renflexis is considered a specialty medication, which means that it will most likely be delivered to your home or readily available at a designated specialty pharmacy.

What are the most common side effects associated with Renflexis?

The most common side effects include infections, infusion-related reactions, headache and abdominal pain. More serious side effects include more life-threatening infections or cancer.

What other biosimilars for Remicade exist?
Renflexis is the 2nd biosimilar that has been approved for Remicade. The other biosimilar, Inflectra, was approved by the FDA a little over 1 year ago on April 5th, 2016.

Renflexis should be available in pharmacies in about six months.

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