FDA Brushes Off Three Petitions on Biosimilar Labeling Guidance

The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns.

The agency states that petitions from AbbVie, PhRMA and a group of institutional investors will be considered when the agency starts finalizing a guidance issued in March that recommends that biosimilar sponsors incorporate information from the reference product into their own labeling. Otherwise, the agency does not intend to act on the petitions and denied the requests in a letter.

Last year, AbbVie filed a petition claiming the FDA approved Sandoz’s biosimilar Zarxio with a label that mimics the labeling of its reference product, Amgen’s Neupogen.