AbbVie Petitions FDA On Biosimilar Labeling

FDA Citizen Petition Tracker

AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose three labeling requirements on biosimilar applicants.

“Biosimilars are not generic drugs and should not be labeled like generic drugs” AbbVie stated, and demanded that the FDA require biosimilars to contain various statements in their labels to distinguish approved biosimilars from their branded counterparts.  AbbVie wants biosimilar labels to state:

  1. that the product is a biosimilar;
  2. that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable);
  3. that the biosimilar’s licensed conditions of use were based on “extrapolation” (if applicable);
  4. that FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable); and
  5. 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.

AbbVie argues that the additional labeling requirements will provide more information for prescribers and “avoid potentially unsafe substitution of biosimilars and reference products.” Furthermore, without such statements in the label, “biosimilar labeling will not reflect the unique licensure provisions established by the BPCIA and will be materially misleading in violation of the FDCA and FDA regulations.” Id.

AbbVie’s petition comes after several FDA actions implying that the Agency would permit biosimilar applicants to copy much, if not all, of the reference product label. For example, in a November 19, 2013 meeting, Sandoz proposed, and the FDA agreed,  that biosimilar and reference product labeling “should be essentially the same.” And in February 2015, the FDA provided the labeling for Neupogen to Sandoz for use “as a template” in developing the labeling for Zarxio. Further, the FDA instructed Sandoz to track the changes made to the Neupogen label and provide explanations and justification of any changes.

AbbVie argues that this is essentially what the FDA requires of applicants seeking to market generic drugs under 505(j). 21 C.F.R. §314.94(a)(8)(iv), but that it would be “legally unsound” for the FDA to adopt the “same labeling” approach.   AbbVie argues that the BPCIA does not have a “same labeling” requirement, and that permitting biosimilars to be labeled as if they are “bioequivalent” would compromise public health and safety, for example because biosimilars may have different immunogenicity profiles than the reference products.

Under the Food and Drug Administration Safety and Innovation Act, FDA has 150 days to respond to AbbVie’s petition. We will keep you posted on the response.

 

 

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