Listing a BLA-Approved Product Competing with Devices in Drug Compendia

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer was launching a new product approved through a BLA that would compete with similar products that are approved as devices. The manufacturer sought to better understand how these competitor products were categorized and optimize how their BLA-approved product would be listed in the pricing and clinical compendia.
PHSI SolutionPHSL examined competitor devices in four different drug compendia. Analysis focused on areas that may differentiate a BLA-approved product from a device. PHSL drafted compendia submission forms to ensure proper and complete documentation related to product naming, description, and pricing was communicated with each drug compendia.
ResultsPHSL recommended communications to drug compendia that ensured the manufacturer’s product was appropriately listed and well-positioned in relation to its device competitors.