Biden budget request scraps interchangeable designation

Along with modest increases in funding for FDA and non-starter prescription drug pricing proposals, President Joe Biden’s FY25 budget asks Congress to make some substantial policy changes. Two of the most interesting proposals would give FDA recall authority over drugs and eliminate the interchangeable biologics pathway.

The White House’s FY25 budget request includes language that would deem all biosimilars to be interchangeable with their reference products and get rid of the separate interchangeability designation. ...