Biosimilar naming convention undecided for now


22 Sep 2016

The TGA says it is continuing to discuss the adoption of a naming convention for biosimilars with other overseas regulators.

The revelation comes following the release of a communiqué from the August meeting of the Biosimilar Awareness Initiative Reference Group, which was set up to “give guidance on the activities of the Biosimilar Awareness Initiative and ensure key messages are clearly articulated and appropriately targeted.”

In the latest meeting representatives from organizations such as the Haematology Society of Australia and New Zealand, Arthritis Australia, the Australian Rheumatology Association and the Gastroenterology Society of Australia were given an overview of the Biological Qualifier (BQ) Scheme adopted by the World Health Organisation in July this year.

The scheme applies a random four consonant code to all biological medicines.

Speaking to the limbic a TGA spokesperson said the scheme, which was yet to be formerly adopted by a national regulatory agency, was currently being considered by the European Medical Agency and the US Food and Drugs Administration.

The TGA’s response to the BQ scheme was also under discussion including with the overseas regulators, the spokesperson said.

“The TGA aims to be internationally aligned on our approach to the evaluation of biosimilars and to minimise any Australian-specific requirements thereby reducing potential barriers to the development of a biosimilars market in this country,” they said.

“Until such time as a final decision is made, the interim policy of naming biosimilars using the Australian Biological Name of the reference product (without a specific biosimilar suffix) will continue”, they added.

The spokesperson reiterated that clear, accurate and unambiguous naming of the active ingredient in medicines was important to minimise prescribing errors and for tracking any problems that might arise following use of medicines.

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