The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial letter indicates that biosimilar labeling guidelines are still in flux while FDA works to finalize its March 2016 Draft Guidance for Industry: Labeling for Biosimilar Products. According to FDA,
“FDA has neither adopted nor abandoned a policy on biosimilar labeling.” Additionally, FDA notes that the labeling for the first biosimilar approvals, Zarxio (filgrastim-sndz) and Inflectra (infliximab-dyab), do not signal agency policy regarding biosimilar labeling. Rather, they reflect the agency’s actions on these specific products.
The petitions from AbbVie, Inc., the United Auto Workers (UAW) Retiree Medical Benefits and other investors, and the Pharmaceutical Research and Manufacturers of America (PhRMA) jointly with the Biotechnology Innovation Organization (BIO) were filed from June through December 2015. FDA notes the overlap between issues raised in the petitions and those addressed by its March 2016 Draft Guidance for Industry: Labeling for Biosimilar Products. The agency is developing a more broadly applicable policy toward biosimilar labeling through this guidance process.
Except for a few issues that were substantively addressed, FDA intends to review the issues raised in the petitions with the comments received in the docket for the Draft Guidance (FDA-2016-D-0643), which “will permit FDA to more efficiently finalize the biosimilar labeling guidance ….” The issues that were substantively denied include a request for a public hearing and an argument premised on the fact that FDA has unlawfully applied a “same labeling” approach. FDA denied that it has used a same labeling approach and reiterated that biosimilar labeling should include essential scientific information from the reference product labeling, with necessary product-specific modifications.
The formal comment period for the Labeling Guidance was extended to August 2, 2016.