Drugs

FDA Chooses Biologic Nonproprietary Suffix Format

FDA has issued a guidance, Nonproprietary Naming of Biological Products, calling for biological products licensed under the Public Health Service Act to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under this convention, the “nonproprietary name for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.” The guidance applies both prospectively and retrospectively.

Application of the naming convention to these biological products should, the guidance says, (1) encourage routine use of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices, and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.

FDA lists four considerations that led it to adopt this naming convention:

enhancing biological product pharmacovigilance by allowing FDA to track adverse events to a specific manufacturer and even to a lot or manufacturing site and to allow surveillance systems to detect safety signals throughout a product’s lifecycle;
ensuring safe use for biological products by preventing inadvertent substitution;
advancing appropriate practices and perceptions regarding biological products to provide a consistent, readily available and recognizable mechanism for patients and healthcare professionals, including providers and pharmacists, to identify the products; and
both prospective and retrospective application of the naming convention to (1) prevent a patient from receiving a product different from what was intended to be prescribed; (2) facilitate manufacturer-specific pharmacovigilance by providing a means of determining which biological product is dispensed to patients; (3) encourage routine use of FDA-designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices for these products; and (4) advance accurate perceptions of these biological products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome