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FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab).  Inflectra is now the second biosimilar approved for sale in the United States, after Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim).  The label for Inflectra contains a statement that it has been “approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.” Currently, Zarxio’s label does not include such a statement, because it was issued before the FDA’s latest guidance for biosimilar labeling.  Inflectra has been assigned the name “infliximab-dyyb”—infliximab plus a meaningless four-character suffix—which is in line with the FDA’s guidance on biosimilar naming.  As with the label, Inflectra is the first product to reflect the FDA’s current practices for naming biosimilars. Zarxio was designated “filgrastim-sndz,” for Sandoz.

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