AbbVie Amends its Citizen Petition to FDA

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The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.


AbbVie is not thrilled with FDA’s stance on biosimilar naming. The company sent an addendum on Aug. 10, 2015 to its original June 2, 2015 Citizen Petition to FDA on the subject, citing various offenses related to FDA statements on interchangeability and the agency’s stance on the inclusion of reference biologic studies in place of biosimilar study information in a biosimilar’s product label.

AbbVie is concerned with an explanation FDA gave the Senate Committee on Heath, Education, Labor, and Pensions (HELP Committee) about interchangeability information on biosimilar labels. In an April 30, 2015 letter to FDA, the HELP committee said that while FDA’s draft guidance acknowledges that knowing a drug’s interchangeability is crucial to making prescribing decisions, the final version of the 2012 document omitted key information about what exactly a biosimilar’s label should say about its interchangeability status. With this guidance deletion, the HELP Committee argued that, “FDA has made its policy on the issue more uncertain.”

AbbVie took particular issue with the fact that FDA told the HELP Committee that all information on interchangeability could be found in The Purple Book and, therefore, did not need to be included on a biosimilar product label. AbbVie countered that this argument goes against the “foundational principles” of FDA law, and wrote that, “The proposition that The Purple Book could cure a material omission in the labeling for a biosimilar is indefensible.” AbbVie added that because The Purple Book does not identify indications or routes of administration for which a product has been found biosimilar to its reference product, it is not an adequate resource to help providers make informed decisions. Only product-specific disclosures on a biosimilar’s label can fully inform healthcare providers, AbbVie argued.


AbbVie to FDA:
Use a biosimilar’s own clinical data in its label

It is also misleading to include study information on another drug in a label for a biosimilar without acknowledging that the studies were not performed on the biosimilar itself, AbbVie wrote. They said that including study information on filgrastim, rather than on the specific biosimilar Zarxio, is a “shortcoming to FDA’s current approach to biosimilar labeling.” Studies comparing the biosimilar and the reference biologic should be part of a biosimilar’s label, AbbVie argued, and should identify whether a biosimilar is interchangeable with its reference product.

Lastly, AbbVie said that multiple new organizations have pointed out issues with the current labeling practices for biosimilars since the company filed its original petition, including the American Pharmacists Association, the American Society of Health-System Pharmacists, the Alliance for Patient Access, Patients for Biologics Safety and Access, the Global Healthy Living Foundation, the Coalition of State Rheumatology Organizations, and the Biosimilars Forum, an organization run by the Generic Pharmaceutical Organization.

Source: FDA