WHO officially scraps proposed naming convention

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The World Health Organisation has publicly confirmed its decision to scrap its proposed naming convention for biologic medicines.

Official confirmation, included in a report of a meeting held in Geneva in May this year, which involved a multi-country consultation on improving access to and use of biosimilars, was expected.

According to the report of the meeting, which was attended by a representative of the Australian Department of Health, "No consensus was reached on whether WHO should continue with the BQ – it should be noted that WHO will not be proceeding with this at present."

The WHO's naming proposal involved the use of a Biological Qualifier (BQ). The BQ code would be comprised of four random consonants in two 2-letter blocks separated by a 2-digit checksum. 

The BQ code was similar to the system adopted by the US FDA, under which biologic medicines are assigned a unique four-letter suffix, but differs greatly from the European 2D barcode on product packaging.

The European system, which has been backed by some companies in Australia, including Novartis, incorporates in the packaging barcode the product code, national identification number, batch number and expiry date.

The TGA is currently consulting stakeholders on the future of its naming convention.

In a recent discussion paper, 'Nomenclature of Biological Medicines', the regulator proposed four options but seemed to favour of the current system under which biosimilars are approved with the same name as their reference biologics.

The other options included retention of the current system with the inclusion in adverse event reports of a product’s trade name, AUST R and batch number, the European or US systems.