FDA Releases Interim Response to AbbVie’s Citizen Petition

Published on: 

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

FDA released an interim response to AbbVie’s June 2015 citizen petition on the labeling of biosimilars, in a Dec. 1, 2015 letter to the company.

According to the letter, FDA has not yet reached a decision on the petition, which requests FDA to clearly label biosimilars under 351 (k) Public Health Services Act. The agency said they were unable to reach a decision on the petition because it rose, “complex issues requiring extensive review and analysis by Agency officials.”

In the petition, AbbVie argued labels should reference whether or not a biosimilar is licensed for fewer uses than its reference biologic. The petition also brought up issues of interchangeability, stating labels should contain information on whether or not the biosimilar is interchangeable with the reference.

In an August 2015 amendment to the petition, AbbVie said it is also misleading to include information from a study not performed on the biosimilar itself on the label. The company asserts there should be a clear distinction between data derived from studies done on the reference biologic and on the biosimilar.


The petition launched after discrepancies arose with the labeling of Sandoz’s Zarxio, a biosimilar of Amgen’s neutropenia medication Neupogen (filgrastim). Zarxio’s label includes information from studies done on filgrastim, rather than on Zarxio. AbbVie called Zarxio’s label a “shortcoming to FDA’s current approach to biosimilar labeling.”

FDA says they will respond to AbbVie’s petition when they have reached a final decision-they did not provide information about when a decision would be released. 

Source: FDA