FDA Denies 3 Biosimilars Labeling Petitions
FDA has denied three separate petitions asking it to take specific actions relating to labeling for biosimilar products and has said it will consider the petitions’ requests as part of comments received on a draft guidance on the topic. The agency says that given the subject matter overlap between the comments and the petitions, it makes sense to consider them together rather than respond to the petitions separately. “Accordingly, FDA is denying these petitions and inviting the petitioners to submit any further comments to the docket associated with the draft guidance,” the denial letter says.
An AbbVie petition asked the agency to require that biosimilar labeling contain (1) a clear statement that the product is a biosimilar that is licensed for fewer than all of the reference product’s conditions of use (if applicable) and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable); (2) a clear statement that FDA has not determined that the biosimilar is interchangeable with the reference product (if applicable); and (3) a concise description of the pertinent data developed to support licensure of the biosimilar.
A United Auto Workers Retiree Medical Benefits Trust petition asked that the agency require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling approach” that the petition says FDA applied to Sandoz’ Zarxio (filgrastim-sndz), and to hold a public hearing on the issue.
Finally, a petition from Pharmaceutical Manufacturers and Research of America and the Biotechnology Innovation Organization asked that the agency require that labeling of biological products licensed under section 315 of the Public Health Services Act (1) state that the product has been approved as a biosimilar for stated indications and routes of administration and identify the reference product; (2) describe the bases for approval for each indication by identifying the relevant data for the reference product and the biosimilar that supports a finding of biosimilarity; and (3) state whether FDA has made a determination of interchangeability with the reference product and include any such finding.
The letter cites FDA’s 3/31 draft guidance on labeling for biosimilar products and the agency’s action in reviewing and approving labeling for Zarxio and Hospira’s Inflectra (infliximab-dyyb). “The agency took these actions on a product-specific basis,” it says, “and they should not be understood to reflect a broader policy on how biosimilar products should be labeled. FDA is continuing to develop its broader policy on this topic, including its positions on the issues raised in the petitions, in connection with reviewing comments submitted to the biosimilar labeling guidance docket and finalizing that guidance.”
While FDA said it will consider the requests in the three petitions as part of the comments on the draft guidance, it used the letter to deny the United Auto Workers request for a public hearing, saying that it would be “administratively burdensome and would unnecessarily delay development and publication of the final version of the biosimilar labeling guidance.”
It also rejected AbbVie’s contention that the agency’s application of a “same labeling” approach to its Zarxio approval was unlawful because Congress did not specify a same labeling requirement for biosimilars in the Biologics Price Competition and Innovation Act. The letter says that AbbVie’s argument that FDA applied a same labeling approach to the Zarxio approved labeling lacks merit. The agency says it is following the applicable statutory and regulatory requirements for biosimilar labeling.