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Category: Labeling

FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA announced the approval of 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. Inflectra’s label and naming reflect the latest FDA guidance.

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Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns.  Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s Neupogen and that it has not been determined to be interchangeable to Neupogen.  Instead, Zarxio’s label is nearly identical to that of Amgen’s Neupogen and does not identify the information provided by Sandoz to FDA to obtain Zarxio’s approval, including information on immunogenicity specific to Zarxio. AbbVie has supplemented its citizen petition urging FDA not to allow biosimilars to be labeled like generic drugs since biosimilars, unlike generic drugs, are not identical to the originator product and requesting distinct labeling for biosimilars.  In briefing U.S. senators on September 17, FDA promised to issue guidance on labeling of biosimilars.  

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FDA Approach to Labeling Treats Biosimilars Like Generics

A recent FDA guidance document eliminated biosimilar labeling information that FDA previously viewed as “necessary” for physicians to make prescribing decisions, including whether the biologic is biosimilar to or interchangeable with the reference product.  The FDA also approved a label for the first approved US biosimilar that omits this information.  The FDA’s actions have drawn criticism from associations of physicians who routinely prescribe biologic medicines and the innovator companies that develop them.

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