FDA Approves the First Biosimilar Medication for Ankylosing Spondylitis and Psoriatic Arthritis

By Spondylitis Association of America

Wednesday, April 6, 2016

On April 5th, 2016 the FDA approved Inflectra / CT-P13, a biosimilar version of the TNF inhibitor infliximab (Remicade) for use in all of infliximab’s indications, including ankylosing spondylitis and psoriatic arthritis. The price of the new biosimilar has yet to be announced, but is expected to be 20 – 30% lower than the current US price of Remicade.

"A biosimilar product [such as Inflectra] is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product [the reference product being Remicade in this case.] The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product,” states the FDA news release on Inflectra’s approval.

"Many believe the new biosimilar will initially be used for new biologic starts and not be substituted, or be interchangeable, for current Remicade use,” says Jack Cush, MD.

"It is important to note that the FDA has not approved [Inflectra] as being interchangeable with Remicade," said Johnson & Johnson’s Chief Biotechnology Officer Jay Siegel in a statement. "For FDA to determine a biosimilar is interchangeable with its reference product, a manufacturer must demonstrate that the biosimilar is expected to produce the same clinical result as the reference product in any given patient. In addition, the manufacturer must demonstrate the risk of alternating or switching between the reference product and biosimilar is no greater than the risk of using the reference product." 

"Approval of Inflectra comes without language or data that would allow forced change from current Remicade use to substituted Inflectra,” further clarifies Dr. Cush.

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