AbbVie Requests FDA Hearing on Biosimilar Interchangeability Guidance
In anticipation of proposed guidance on biosimilar interchangeability, AbbVie is requesting that the FDA hold a hearing to ensure the agency considers all viewpoints.
The request, made in a citizen petition dated Dec. 16, says the hearing would allow stakeholders — including manufacturers and payers — to examine multiple topics, such as the implications of when multiple biologics may be interchangeable with a single reference product, but not with each other.
AbbVie also is asking the FDA to require that biosimilars should demonstrate equivalence to a reference product in all uses. That requirement would apply even if the biosimilar applicant doesn’t intend to seek approval for all of the uses.
AbbVie also asks the agency to make it clear that the standards for establishing interchangeability differ from those for determining biosimilarity.
Interchangeability has taken center stage at the FDA, with CDER Director Janet Woodcock identifying guidance on the topic as one of the agency’s most important upcoming tasks during testimony to a Senate subcommittee last September. Guidance on interchangeability could come as early as the first quarter of 2016, according to Kevin Nelson, a partner with Duane Morris, who spoke during an October FDAnews webinar.
Word of the petition comes a month after Amgen made its move to compete with AbbVie’s Humira with the filing of its first biosimilar application.
Read the petition here: www.fdanews.com/12-29-15-Petition.pdf.