FDA, USP spar over biologics monographs

FDA has thrown its support behind a proposal in President Donald Trump's FY20 budget that would exclude biologics and biosimilars from meeting monograph standards established by the U.S. Pharmacopeia for small molecules, a measure that USP opposes.

The administration claims removing the requirement will make it easier for biosimilars to enter the market and increase competition, as well as reduce costs for biological products. USP, however, believes the proposal poses a risk to medicine quality and could impede patient access...