AbbVie Requests That FDA Set Clear, Transparent Labeling for Biosimilars

June 9, 2015

AbbVie filed a citizen petition last week urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products.

Labeling should identify the product as a biosimilar and state whether the product is interchangeable with its reference biologic, the drugmaker says in the petition. It should also describe the data supporting the biosimilar’s approval and distinguish that from data derived from the originator.

In particular, AbbVie warns against applying the “same labeling” approach to biosimilars that is used for generics, saying to do so could be misleading and compromise patient safety.

On March 6, the FDA approved the first biosimilar product in the U.S. — Zarxio (filgrastim-sndz), developed by Sandoz as a biosimilar to Amgen’s cancer treatment Neupogen (filgrastim). In its petition, AbbVie notes that Zarxio’s label mimics the approved labeling for Neupogen, suggesting the FDA plans to apply the “same labeling” requirement.

The FDA doesn’t comment on pending citizen petitions. The agency has promised draft guidance on biosimilar labeling before the end of the year.

Read the citizen petition here: www.fdanews.com/06-15-AbbVie-Petition.pdf. — Jonathon Shacat