FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should include a “core name” followed by a four-letter suffix. The core name typically will be the USAN Council name for the Reference Product (RP)….
The August, 2016, edition of the Journal of Managed Care & Specialty Pharmacy published the results of a survey designed to measure pharmacists’ view on biosimilar naming conventions. (See our previous posts here and here for more information regarding the naming of biosimilars.) The survey found that pharmacists would generally prefer…
Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed four-letter suffixes and, optionally, analyses supporting those suffixes. FDA has now announced that it is withdrawing…