AbbVie seeks unique labels for biosimilars

AbbVie Inc. (NYSE:ABBV) filed a Citizen's Petition with FDA on Wednesday challenging the agency's decision to make biosimilar product labels mirror those of reference products. The company, which faces potential competition from biosimilar versions of its Humira adalimumab, asked that FDA require that labels clearly distinguish between biosimilars and reference biologics, highlight clinical data used to approve a biosimilar, and note conditions of use that were based on extrapolation of clinical data in a different indication. AbbVie's proposals would allow it and other manufacturers of original biologics to inform physicians and patients of the more limited clinical testing required for biosimilars.

AbbVie also asked that biosimilar labels explicitly state when a biosimilar is not interchangeable with its reference biologic, and distinguish between data derived from studies of the reference biologic vs. the biosimilar product. ...