Makary: FDA To Eliminate Comp Efficacy Studies As Part Of Major Biosimilars Announcement

FDA Commissioner Marty Makary signaled a major drug pricing announcement from HHS later today will aim to significantly reduce drug prices by boosting biosimilars -- including new FDA guidance eliminating comparative efficacy study requirements, calls for all biosimilars to be interchangeable with their reference products, steps to increase onshoring and pleas for biosimilars makers to significantly lower prices.