AbbVie seeks clarity on biosimilar interchangeability

In a Citizen's Petition, AbbVie Inc. (NYSE:ABBV) asked FDA to require that companies seeking interchangeability status for a biosimilar demonstrate interchangeability with a reference product for each of the reference product's approved conditions of use. AbbVie's proposal would apply regardless of whether a biosimilar manufacturer is seeking approval for some or all the conditions of use included on the reference product's label.

AbbVie also asked FDA to hold a public hearing and issue guidance on interchangeability. The company said FDA's guidance should address standards for determining interchangeability, particularly for biosimilars used to treat chronic conditions. ...