A survey of Australian prescribers’ views on the naming and labelling of biologicals

Category: Review Article
Author(s): ,
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Keywords: Australia, biologicals, labelling, naming, prescribers

Introduction: As the number of biosimilar approvals in Australia increases, it will be important to establish a fast track regulatory framework to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. Before establishing a new regulatory framework, it is essential to understand how biologics and biosimilars are approved and regulated. The Alliance for Safe Biologic Medicines (ASBM) has asked prescribers of biosimilars in Australia for their opinions on how biosimilars are used and how they should be regulated. Currently, biologics and biosimilars are approved by Australia’s Therapeutic Goods Administration (TGA). The country’s Pharmaceutical Benefits Advisory Committee (PBAC) has indicated it will consider pharmacy level substitution of biosimilars for reference biologic medicines on a ‘case by case basis’.
Methods: In June 2016, the ASBM asked 160 prescribers in Australia to take a non-validated survey to gauge their opinions on the naming of biologicals and biosimilars and how the use of these medicines is recorded. Prescribers were also asked for their views on substitution and about their familiarity with, knowledge of, attitudes to and beliefs in, biosimilars.
Results: Nearly all (97%) of respondents consider the best way for TGA to differentiate a biosimilar medicine from its reference biologic is either with the same non-proprietary scientific name and a differing prefix or suffix, or with a completely unique name. Those surveyed used brand name (39%) and non-proprietary scientific name (38%) in about equal frequency when recording reference biologics and biosimilars in patient records. 48% of respondents always or sometimes include batch numbers when reporting adverse events. 89% of respondents thought it critical or very important that they be notified in the event of a pharmacy-level substitution. 61% thought that the TGA should be responsible for providing the primary advice to Government that a product is suitable for pharmacy level substitution, while only 33% thought that the PBAC should be responsible.
Conclusions: Bearing in mind that this survey had a small sample size was not validated, most respondents agreed that TGA should insist on distinct non-proprietary scientific names for all biosimilars and reference products, and most agreed that robust data are needed to support sole substitution. While the prescribers surveyed use several different information sources to learn about the medicines they prescribe, the proportion of prescribers using any one of these sources was small. Perhaps because of this, half the prescribers surveyed thought, incorrectly, that biosimilars and originators are approved through the same regulatory process.

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