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FDA Releases Final Guidance for ‘Nonproprietary Naming of Biological Products’

January 16, 2017

The FDA guidance describes the agency's current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include an FDA-designated suffix. It recommends that previously approved, originator drugs also have distinguishable suffixes and notes that distinguishing suffixes should help minimize inadvertent substitution of any products that have not yet been determined to be interchangeable. 

Under this naming convention, FDA will designate a distinguishing suffix that is devoid of meaning and composed of four lowercase letters in the nonproprietary names for originator biological products, related biological products, and biosimilar products. The suffix will be attached to each product’s core name with a hyphen. FDA is continuing to consider the appropriate suffix format for interchangeable products.

The FDA said it has carefully considered the appropriate naming convention to help ensure the safety of patients receiving biological products, enhance patient and prescriber confidence, and maximize the success of biosimilar and interchangeable biological products. 

“The Alliance for Patient Access is pleased that FDA has determined that distinguishable names are vital for the expanding biosimilars marketplace," Brian Kennedy, executive director of the alliance, said in a statement. "Biological medications’ four-letter suffixes will differentiate their nonproprietary names, allowing physicians to accurately determine which medication a patient takes and to address any problems that might impact patient safety."

While Kennedy said the group "appreciate(s) FDA’s efforts to engage all stakeholders and integrate their input into the final guidance," he had hoped a more "memorable" naming convention had been established. “According to this guidance, however, the four-letter suffix will be randomly generated and devoid of any meaning," Kennedy said. "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." But, he thanked the agency for reiterating the primary focus on pharmacovigilance and patient safety in the use of biological medications.

Meanwhile, the American College of Rheumatology (ACR) applauded the agency final guidance recommending distinct suffixes for biosimilars and reference biologics, which rheumatologists say will be critical to ensuring patient safety and prescriber confidence in the era of biosimilars. 

"The American College of Rheumatology 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 pharmacovigilence," said Dr. Angus Worthing, M.D., FACP, chair of the ACR's government affairs committee. "This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently and efficiently as possible." 

By Mike Botta 

(Sources: American College of Rheumatology, EurekAlert, Alliance for Patient Access, FDA)