AbbVie does not like that the labeling for Sandoz’s Zarxio, the first FDA-approved biosimilar, does not say that it is not interchangeable with the referenced biologic, Neupogen, FDA Life reported.
In addition, they say the label, approved by the FDA, does not say it is a biosimilar.
They formally filed a supplement to their earlier Citizen Petition, challenging the FDA’s implementation of the Biologics Price Competition and Innovation Act on Aug. 10, according to the website.
