Biosimilar Labeling Practices Under Fire in New Citizen Petition

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In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”


The strategic timing of a new indication awarded to Amgen’s granulocyte colony stimulating factor Neupogen (filgrastim) means that the biosimilar for Neupogen and its reference product do not share the same number of indications on their labels. Adding the indication to the innovator product means that the two products cannot technically share the same exact label.

On March 30, 2015, FDA approved use of Neupogen to treat adult and pediatric patients acutely exposed to myelosuppressive doses of radiation. The drug helps those with radiation injuries by facilitating recovery of bone marrow cells that develop into white blood cells.

The approval came less than a month after Sandoz’s biosimilar for Neupogen was approved by FDA for all of Neupogen’s indications; however, because the indication for radiation events occurred after the biosimilar was approved, the reference product has one more indication listed in its label than does the biosimilar product.

Stacie L. Ropka, PhD, JD, attorney at Axinn, Veltrop & Harkrider LLP, notes that the April 2015 guidance from FDA allows a biosimilar applicant to obtain licensure of a proposed biosimilar product for fewer than all conditions of use for which the reference product is licensed. The 351(k) application for the biosimilar, however, "must include information demonstrating that the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling submitted for the proposed biosimilar product have been previously approved for the reference product." Because of the timing of the 351(k) application for Sandoz's Zarxio (filgrastim-sndz), it would appear that Sandoz’s product cannot be a candidate for use for the radiation injury indication, unless it is prescribed off label.


“If there are patents directed to the new indication that will expire after Sandoz (plans) launch, Sandoz may elect to not include this indication in its label,” Ropka told BioPharm International. “If Sandoz elects to forgo the new indication, for whatever reason, it can. And in so doing, the Sandoz label will not be exactly the same as Amgen’s Neupogen label."

In fact, AbbVie just filed a Citizen’s Petition to FDA on the labeling of biosimilars, calling the current labeling practice “legally unsound.” AbbVie argues that a biosimilar needs to be clearly labeled as a follow-on product, and it should be clear that the product may not be licensed for all indications for which the original drug has obtained approval and may not be interchangeable with the reference product. The petition also requests that the data used to determine biosimilarity be included in the label for the follow-on product, and that these data be clearly labeled with the term “biosimilar”; a word which is currently absent from Zarxio’s label.  According to the text in the petition, FDA instructed Sandoz to “track any changes made to the Neupogen labeling and provide annotations to explain and justify any such changes.” At press time, the Sandoz label for Zarxio did not have any annotations explaining the difference between its label and the Neupogen label regarding the additional Hematopoietic Syndrome of Acute Radiation Syndrome indication that appears on the Neupogen label.

AbbVie asserts that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) has different provisions on labeling than those of the Abbreviated New Drug Application (ANDA), which govern labeling for small-molecule generics. Labeling biosimilars the same as their reference products would, according to AbbVie, “result in labeling that omits material information necessary for safe and informed prescribing, and would exacerbate, rather than dispel, misconceptions among prescribers regarding biosimilars."

AbbVie specifically calls upon FDA in the petition to require that the label for a biological product licensed under section 351(k) of the Public Health Service Act 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)

  • 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.”

Source: FDA