As for pharmacy benefit managers, they prefer to keep biosimilar naming simple.25 A survey of members of the Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists found that the majority (75%) of respondents indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same nonproprietary name. In contrast, just 37% expressed confidence in substituting when the prefix or suffix of the drug name differed . 26

What about the views of practicing physicians who will be charged with prescribing? Interestingly, 80% of prescribing physicians use the brand name to refer to both the brand and generic drug.16 The majority (99%) also refer to biologic agents by name when recording prescribed drugs in patient charts and reporting AEs. Less than 1% use national drug code numbers for patient records or AE reporting. In addition, more than 76% view products with the same scientific name as structurally identical and assume that a patient can be safely switched from one such product to another.27


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Sumant Ramachandra, MD, senior vice president at Hospira, voiced a typical viewpoint in a news article appearing Managed Care in 2013.25 “As a physician, it’s not my job to remember 10 different versions of a drug’s name. Three pharmacist organizations have said a unique name is not needed; so if anything, this is just one impediment to the adoption of more affordable medicines in the US,”

The arguments for and against a suffix in the naming convention biosimilars clearly shows that there is no easy solution. Although the use of a suffix provides a unique identification, it can confuse prescribing physicians and dispensing pharmacists; however, potential safety issues may arise when biologic agents are not distinguished by a suffix code, especially when interchangeability is not indicated.28

As for the FDA’s goals of traceability and AE monitoring for biosimilars, no clinical history exists through which to evaluate traceability and AE reporting. A study that investigated the traceability of AEs for branded and generic drugs with identical nonproprietary names found that generic and branded products with the same name have poor AE traceability.29 The study also found that more AEs were attributed to branded products even when those AEs were, in fact, associated with  generics. AE reporting also has been evaluated for 2 off-patent biologics, somatropin and human insulin.30 That study found that, for these biologics with different names, reporting practices are inconsistent and manufacturer identifiability and traceability are lacking. These findings suggest that, although a valid argument for a consistent naming convention for biosimilars exists, traceability and AE reporting are not solely determined by the naming convention and strategies are needed to improve reporting practices.

Summary and clinical applicability

The FDA’s proposal for the addition of a 4-letter suffix to the nonproprietary biologic name has stimulated a national debate among key stakeholders. Although the final decision on naming is not likely to satisfy everyone, the views of the end users—the physicians and pharmacist who will prescribe and dispense the agents and patients who will use them— need to be taken into consideration in making the final decision. Naming of biosimilars has important clinical implications as regards drug interchangeability and substitution, pharmacovigilance, safety, and physician prescribing habits.

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References

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