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T-31: What’s in a Name? Distinguishable Naming and its Role in PV for Biosimilars: What do Australian Physicians Think?





Poster Presenter

      Harry Gewanter

      • Immediate Past Chair
      • Alliance for Safe Biologic Medicines
        United States

Objectives

To determine how Australian physicians identify biologic medicines in patient records and in adverse event reporting, and to gather physician perspective on the importance of distinguishable naming

Method

The Alliance for Safe Biologic Medicines (ASBM) conducted web-based surveys among 160 Australian physicians with specialties in dermatology, endocrinology, oncology, nephrology, neurology, rheumatology, and GI to uncover opinions on biologic product naming.

Results

Respondents practiced in one of the following settings: public hospital (46%), private hospital or clinic (46%), or academic medical center (11%); a majority (94%) had at least 6 years in clinical practice, with 42% having between 11 and 20 years in practice. Rheumatologists, oncologists, and gastrointestinologists were most heavily represented (25% each), with dermatologists, endocrinologists, nephrologists, and neurologists making up 6% each. Among those surveyed, most used either the medication brand name (39%) or scientific name (25%), or both (34%) in identifying and reporting adverse events associated with biologic medicines. Highlighting the importance of distinguishable names for biologic and biosimilar medicines, our survey indicated that most physicians believed using the same non-proprietary scientific name for two distinct medicines could lead to the belief that the two medicines were structurally identical (52%), or that both medicines were approved for the same indications (80%), which may or may not be the case. A majority of respondents (76%) believed it was important for TGA (Therapeutic Goods Administration) of Australia to require distinguishable non-proprietary names for biologics and biosimilars, with 38% preferring a distinguishable prefix, 29% preferring a distinguishable suffix, and 30% preferring an entirely different non-proprietary name for the biosimilar and the reference product.

Conclusion

Biosimilars are similar but not identical to the biological medicine they are based on. It is important that health care practitioners have a method to facilitate accurate identification of biologic products, as a way to monitor a patient’s response to a medicine as well as track any side effects. This is also important for ongoing pharmacovigilance by regulatory authorities. One simple way to achieve this is using distinguishable nonproprietary names. Regulatory bodies around the world have acknowledged the need for distinguishable names for biologic and biosimilar medicines. Our survey indicated that distinguishable non-proprietary names are important to Australian physicians prescribing biologic medicines. This is in line with the opinions of physicians prescribing biologics in the US, Latin America, and Canada as determined through previous ASBM surveys. ASBM supports the use of a distinguishable meaningful, user friendly, suffix related to the company manufacturing the biologic, added to the end of a shared root name. This will enable different biologic products to be distinguished from each other while ensuring a clear link to the reference product. We believe that a memorable suffix is preferable to a random series of characters, as it will minimize confusion, while enabling a connection to the biologic manufacturer, facilitating traceability and accountability. These Australian physician survey data were shared for the first time in mid-February in a series of meetings with Australian Department of Health, the TGA, and senior Health officials in Parliament, to highlight educational challenges, which if properly addressed, can help increase biosimilar utilization in Australia.