The US Food and Drug Administration (FDA) has issued a final guidance document for the naming of reference biological products and biosimilars. The advisory calls for the use of a nonproprietary name that includes a unique, randomly generated FDA-designated 4-letter suffix. The FDA explained that the new naming convention should facilitate increased pharmacovigilance, allow for accurate identification of products by patients and health care practitioners, and minimize inadvertent substitution of products that are not interchangeable.
The FDA is still developing recommendations on an appropriate suffix format for interchangeable biosimilar products, which it addressed with a draft guidance document published earlier this month.
“Under this naming convention, the nonproprietary name designated 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 FDA document advises.
The use of nonproprietary names with a unique suffix, noted the FDA, will prevent inadvertent substitution of these products and promote greater safety for patients. This is opposed to the use of a proper name, which could be shared by multiple manufacturers of the same product; however, many biologics, the FDA warned, can be licensed for different indications or may be approved for certain indications using specific administration methods not licensed for all indications.
The aim, it concluded, was to avoid this type of confusion and create a direct link between a biologic and its manufacturer using the suffix system.
“The American College of Rheumatology (ACR) has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substitution, increase prescriber confidence and uptake of biosimilars, and ensure [pharmacovigilance],” said Angus Worthing, MD, FACP, chair of the ACR’s Government Affairs Committee, in a press statement.
“One of our top priorities is to ensure that more affordable treatments reach our patients as quickly as possible, so we applaud the FDA’s measured and thoughtful approach to addressing provider confidence concerns while also prioritizing the safety of our patients,” Dr Worthing added.
Brian Kennedy, executive director of the advocacy group Alliance for Patient Access, also praised the FDA’s call for distinguishable nonproprietary nomenclature for biosimilars, but questions the method to determine each product’s 4-letter suffix and its ramifications for patient safety.
In a press statement he explained: “According to this guidance…the four-letter suffix will be randomly generated and devoid of any meaning. As patient advocates, we would have preferred a memorable suffix, which is the surest way for patients and providers to know which medication is being taken.”
Nonproprietary naming of biological products: guidance for industry. US Food and Drug Administration: Washington, DC. Published online January 13, 2017. Available at: http://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed January 26, 2017.