Experts: Biologic Product Monographs Do Not Impede On FDA’s Authority

Updated Story: This story has been updated to include a comment from FDA. Some biologics experts are perplexed by the Trump administration’s argument that subjecting biologics products to United States Pharmacopeia (USP) monographs would hamper innovation. FDA argues the monographs set rigid standards for biosimilars to prove they’re highly similar to their reference products, but the experts say the agency is the one with the authority to determine similarity as USP monographs only set up quality standards...