Sharpless Hails Biosimilar Guidance As Solution To High Insulin Prices

Acting FDA Commissioner Ned Sharpless predicts the agency’s biosimilar interchangeability guidance will bring down insulin prices by triggering interchangeable biosimilar competition. Some are skeptical of that claim, but former FDA Commissioner Scott Gottlieb, who spearheaded the guidance while at the agency, said Friday (May 10) that he also expects strong biosimilar insulin competition and, at least, it “can’t get any worse.” Due to a regulatory fluke, insulin and three other biologics are regulated as drugs. Obamacare changed that. Starting next...