Aaron S. Kesselheim, MD, JD, MPH

One in 5 of the highest-revenue drugs of 2022 was exclusively approved for rare conditions, accounting for more than 7% of US pharmaceutical spending.

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.

This article describes a recently finalized CMS rule addressing the permissibility of co-pay accumulator adjustment programs (CAAPs) when no generic is available.

Changes in generic drug appearance occur often. Patients’ and pharmacists’ responses to those changes vary, with some patients stopping their medication or using it less.

From 2001 to 2011, the US Food and Drug Administration approved 9 single-enantiomer drugs with racemic precursors. None showed pre-approval evidence of improved efficacy over the racemic precursor.