FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling.  On May 19, 2016, FDA issued an interim response indicating that “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials.  This interim response is provided in accordance with FDA regulations on citizen petitions (21 CFR 10.30(e)(2)).  We will respond to your petition as soon as we have reached a decision on your requests.”

At the time UAW submitted its Citizen Petition, FDA’s actions in connection with Sandoz’s Zarxio® biosimilar product had implied that FDA would adopt a “same labeling” approach.  Since that time, FDA has released draft industry guidance on biosimilar labeling that departs somewhat from the “same labeling” approach.

Stay tuned to the Big Molecule Watch for further developments.