Header graphic for print
Biosimilars Law Blog

Category Archives: Biosimilar labeling

Subscribe to Biosimilar labeling RSS Feed
Posted in Biosimilar labeling, Biosimilars Patent Exchange, News & Events

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the

Posted in Biosimilar labeling, News & Events

FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process

The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial letter indicates that biosimilar labeling guidelines are still in flux while FDA works to finalize its March 2016 Draft Guidance for Industry: Labeling for Biosimilar Products. According to FDA,

Posted in Biosimilar labeling

AbbVie Challenges FDA Biosimilar Labeling

In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio (filgrastim-sndz) as a biosimilar to Neupoen (filgrastim).  As we previously blogged, the prescribing information FDA approved for Zarxio seems to follow a “generic drug” model; the Zarxio labeling is