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European doctors have insufficient knowledge of biosimilars Posted 28/03/2014

The Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilar medicines companies in the US, published results of a survey on 18 March 2014, which showed that physicians in Europe have insufficient knowledge of biosimilars [1].

The survey, which was carried out in the third quarter of 2013, questioned 470 European physicians across five countries (France, Germany, Italy, Spain and UK) about their prescribing habits and knowledge of biosimilars. Specialists in nephrology, rheumatology, dermatology, neurology, endocrinology and oncology were included in the research, which was carried out via a 15 minute web-based survey.

The results showed that although almost all of the physicians prescribed biologicals (92%), only 22% considered themselves as ‘very familiar’ with biosimilars. Whilst the majority (54%) have only a basic understanding of biosimilars, and 24% of participants cannot define or have not heard about biosimilars. The survey did show, however, that only 4% of physicians surveyed had never heard of biosimilars.

Naming
The results also showed that most physicians (62%) used brand names when prescribing and reporting adverse events for biologicals. Despite this fact the ASBM still concluded that the use of distinguishable International Nonproprietary Names (INNs) for all biologicals, including biosimilars, ‘is critical to further strengthen and facilitate patient safety through effective pharmacovigilance’. They backed up this conclusion by the fact that survey results showed that 53% of respondents thought that medicines with the same non-proprietary name were structurally identical and 61% believed that they were approved for the same indications.

Substitution
On the issue of substitution, the survey revealed that 72% of physicians considered it ‘critical’ or ‘very important’ to decide whether a patient should receive an originator biological or a biosimilar. Whilst 77% considered its important to receive notification of a switch, with only 3% of physicians considering pharmacy level substitution completely acceptable.

The ASBM has previously published its view on unique naming for biosimilars and has claimed that if common non-proprietary names are used, patients will not know which drug they are getting [1]. Advocates for a common name for biosimilars, on the other hand, are concerned that there could be the possibility of overdosing or misdosing if different names are used, as a patient could inadvertently be prescribed two versions of the same biosimilar [2].

The results of this survey indicate that the understanding of biosimilars is not yet widespread among European physicians and highlights the need for raising awareness.

A comprehensive paper on the European Prescribers Survey will be published in the forthcoming issue of GaBI Journal, see link below on the initial information.

ASBM 2013 European Prescribers Survey Report

If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here

Related articles

GPhA proposes using manufacturer names to distinguish biosimilars

WHO naming of biosimilars

EU majority says same INNs for biosimilars

References

1.   GaBI Online - Generics and Biosimilars Initiative. ASBM publishes paper on biosimilar naming [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from: www.gabionline.net/Biosimilars/General/ASBM-publishes-paper-on-biosimilar-naming

2.   GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances

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