Regulatory Focus™ > News Articles > TGA Consults on Biological Naming

TGA Consults on Biological Naming

Posted 28 July 2017 | By Michael Mezher 

TGA Consults on Biological Naming

Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems.

According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evidence of such adverse events to date.

Regardless, TGA says that in order to be able to investigate adverse events, "accurate information about exactly which biological medicine was involved must be captured."

But selecting a naming convention for biologics has proven to be a contentious issue for both regulators and industry.

"Given international developments for naming of biological medicines, the TGA now intends to consult on whether there is a need in Australia for additional naming requirements," the agency says.

As of right now, TGA follows the European convention of assigning both biosimilars and their reference biologics the same international nonproprietary name (INN). However, the European Medicines Agency (EMA) will require a barcode on the packages of most medicines by 2019, which it says could be used to identify biologics manufacturers for pharmacovigilance purposes.

On the other hand, the US Food and Drug Administration (FDA) and the World Health Organization (WHO) have proposed naming conventions that would add a four-letter suffix to the nonproprietary names of all biologics.

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) has taken a different route by requiring biosimilars to bear an identifier (BS) followed by a number indicating the order in which the biosimilar was approved.

For the public consultation, TGA is asking for input on four specific proposals:

  1. Maintain the status quo;
  2. Maintain the status quo with additional activities to promote the inclusion of identifying information such as a product's trade name, registered number (AUST R) and batch number in adverse event reports;
  3. Further align with EMA by adopting a barcode system; or
  4. Adopt a suffix-based system in alignment with FDA's.

For the barcode option, TGA says it wants to know what sort of system and level of serialization the barcodes should use, and what sort of financial impact a barcoding requirement would have on drugmakers.

For the suffix-based option, TGA says it wants feedback on whether to use the same names and suffixes as FDA for specific products or develop its own system for adding suffixes. TGA also says it wants input on whether such a system should apply retroactively, or just to newly approved biologics.

TGA, Consultation Document

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.