Tony Hagen is senior managing editor for The Center for Biosimilars®.
The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.
Biosimilar name suffixes are intended to aid in tracking these medicines and improve ability among health care providers to distinguish between these and other medicines; however, a study indicates that providers and health care administrators may struggle to find utility in these 4-letter appellations.
Biosimilar suffixes take the form of random jumbles of letters—deliberately devoid of meaning—such as “awwb,” which is tacked onto the end of the Amgen version of bevacizumab (bevacizumab-awwb, Mvasi). In a study presented at the American College of Rheumatology (ACR) Convergence 2020, investigators set out to evaluate how much providers and administrators know about biosimilars and whether they perceive the FDA’s naming convention as adding utility and reliability to the prescribing process.
Investigators said they found great variation in how well those surveyed understood basic concepts about biosimilars and a lack of appreciation for the suffix naming convention. “These survey findings suggest a knowledge gap with regard to biosimilars and lack of consensus about the usefulness of employing the 4-letter character suffix in clinical practice,” the authors wrote.
The survey included 83 prescribers and health care administrators such as pharmacists, nurses, and medical coders, an 18% response rate. Surveys were sent to individuals at the University of Pennsylvania Health System and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in the Philadelphia area. Providers received a survey if they had previously prescribed a biosimilar.
Investigators said the general knowledge of biosimilars was “rather poor.” Just 52% (28) of respondents were able to answer correctly whether a biosimilar differed from a generic medicine (it does). And although suffixes are intended to help improve pharmacovigilance, 67% of respondents indicated that they used the brand name of the biosimilar in clinical practice to distinguish between biosimilars and their reference products. “Only a minority of respondents [27%] reported regular use of the 4-letter suffix to identify biologic therapies,” the authors wrote.
According to the findings, 85% overall said they find it easier to remember the brand name of a biosimilar than its nonproprietary name and suffix.
Among prescribers, 77% (51) answered correctly that a biosimilar has comparable efficacy, safety, and immunogenicity compared with an originator product. Among administrators, 94% (16) got the question right.
The survey results indicated 42% (28) of providers answered correctly that biosimilars are not generics, vs 88% (15) of administrators. And when it comes to knowing that, by regulatory standard, biosimilars must have the same (“exact”) amino acid sequence as the originator product, 32% (21) and 29% (5) of prescribers and administrators, respectively, answered correctly.
Investigators said 52% (34) of prescribers and 53% (9) of administrators answered correctly that there is variation between manufactured product batches whether they are originators or biosimilars.
“We hypothesize that lack of overall familiarity with biosimilars may have contributed to less comfort with the naming convention,” investigators wrote.
According to the survey, 32% of providers said they feel that the use of brand names for biosimilars introduces commercial bias in clinical decisions. And 21% of providers said the 4-letter suffix induces patients to believe there are “important differences” between biosimilars and originator products. Investigators said 32% of prescribers and 57% of administrators responded that suffixes cause inefficiencies because they conflict with other naming systems.
Of responders who said they were “still in training,” 27 (93%) were residents or fellows.
A recent column by Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, examines some of the issues behind biosimilar suffixes.
Lavery C, Olave M, Leonard C, et al. Knowledge of biosimilars and perceptions of biosimilar naming conventions in clinical practice. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 1605.