On January 12, 2017, the U.S. Food and Drug Administration ("FDA") released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency's ongoing efforts to implement the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The Guidance applies to "originator product[s], related biological product[s]1, and biosimilar product[s]." Under the FDA's current thinking, the naming convention would be both prospective and retrospective in effect, and would apply to both newly licensed and previously licensed products.
Under the Guidance, biological products will be identified by a nonproprietary name or "proper name," consisting of a "core name" plus an FDA-designated suffix. The core name will generally consist of the name designated by the United States Adopted Names Council, and will be the component of the name that will be common to "an originator biological product and any related biological product, biosimilar product, or interchangeable product." A four letter non-proprietary suffix will be appended to this core name to generate the proper name for the product. The Guidance indicates that it does not apply to interchangeable products with respect to the four letter suffix. It states that the FDA is "continuing to consider the appropriate suffix format for interchangeable products," but no timeframe for a decision is provided.
The four letter suffix must consist of at least three different letters, be a unique sequence that is devoid of meaning, and have no relationship to any other drug product or be misleading to consumers. Applicants are instructed to propose up to ten suffixes in the order of the applicant's preference. The FDA offered several illustrations as to how an originator product and a biosimilar product that share the same core name will be designated under this framework. For example, for products sharing the core name "replicamab," the assigned nonproprietary names may be "replicamab-cznm" or "replicamab-hjxf." That is, originator products would also be subject to the suffix nomenclature. The Guidance also indicates that the FDA may continue, on a limited basis, to assign prefixes to a unique proper name in addition to a suffix where "necessary to ensure patient safety."
The FDA believes that applying the naming convention provided in the Guidance will accomplish several goals, including (1) "facilitat[ing] pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances,"(2) "facilitat[ing] accurate identification of these biological products by health care practitioners and patients," and (3) "minimiz[ing] inadvertent substitution of any such products that have not been determined to be interchangeable."
Footnotes
1 The Guidance defines "related biological product" as "a biological product submitted in a Biologics License Application (BLA) under section 351(a) of the Public Health Service Act (i.e., a stand-alone BLA) for which there is a previously licensed biological product submitted in a different section 351(a) BLA that contains a drug substance for which certain nomenclature conventions (e.g., United States Adopted Names (USAN) Guiding Principles) would be expected to provide for use of the same drug substance name."
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