Survey highlights the importance of unique names for biosimilars

Biosimilares/General | Posted 29/11/2013 post-comment0 Post your comment

A report released by the Alliance for Safe Biologic Medicines (ASBM) on 22 November 2013 highlights the importance of using unique names for identifying biosimilars.

Naming 3 V13J04

US-based ASBM surveyed more than 470 prescribers, including nephrologists, rheumatologists, dermatologists, neurologists, endocrinologists and oncologists, from France, Germany, Italy, Spain and UK.

ASBM Executive Director, Mr Michael Reilly, presented the results of the survey at the Drug Information Association Biosimilars Workshop in Dublin, Ireland, on 22 November 2013.

Key findings from the survey include:

  • 53% of physicians surveyed felt that an identical non-proprietary name implies identical structure – which will not be the case for biosimilar medicines
  • 61% of surveyed physicians said that identical non-proprietary names imply that the medicines are approved for the same indications – which is not necessarily the case
  • 24% of reporting physicians record only the non-proprietary name of the biological product in the patient record.

ASBM concludes from these responses that this demonstrates the need for distinguishable non-proprietary names to be given for all biologicals. ASBM also points out that these results are also in line with results of a survey that the Alliance carried out in September 2012, which examined practices and perspectives on biosimilar naming and substitution in 350 physicians in the US.

The group has been calling for distinguishable names for biologicals in order to ensure patient safety. They claim that if a common non-proprietary name were used, patients would not know which drug they are getting. Whereas, advocates for a common name for biosimilars are concerned that there could be the possibility of overdosing or misdosing if different names were used, as a patient could inadvertently be prescribed two versions of the same biosimilar [2].

Related articles

Naming requirements in Australian biosimilars guidance

ASBM publishes paper on biosimilar naming

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances

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Source: ASBM

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