Sandoz disputes AbbVie's interchangeability argument

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) asked FDA to reject a Citizen's Petition from AbbVie Inc. (NYSE:ABBV) requesting that biosimilar sponsors demonstrate interchangeability with a reference product for each of the reference product's approved indications.

AbbVie submitted the petition last year, asking the agency to hold a public hearing and issue guidance to address standards for determining interchangeability (see BioCentury Extra, Dec. 29, 2015). ...