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Biosimilars Law Blog
Posted in Biosimilar labeling

AbbVie Challenges FDA Biosimilar Labeling

In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio (filgrastim-sndz) as a biosimilar to Neupoen (filgrastim).  As we previously blogged, the prescribing information FDA approved for Zarxio seems to follow a “generic drug” model; the Zarxio labeling is essentially the same as Neupogen’s, except for details regarding the administration of the product, which differ.  The labeling contains none of the substantial clinical or preclinical data submitted in the Zarxio application (see here), and which FDA presumably relied on in finding the product to be biosimilar and safe and effective; only Neupogen data are found in the Zarxio labeling.

The AbbVie petition requests that FDA require that the approved prescription drug labeling for biological products licensed under section 351(k) of the PHSA contain:

  • A clear statement that the product is a biosimilar, that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable), and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable);
  • A clear statement that FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable); and
  • A concise description of the pertinent data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from studies of the biosimilar from data derived from studies of the reference product.

There is an open docket, FDA-2015-P-2000, while FDA considers the petition submitted June 2, 2015.