TGA Releases Response to Stakeholder Naming Consultation

On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the value of distinguishing suffixes.

In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.

Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.

Read more about the TGA response here. 

On May 26, 2015 Australian Health Minister Sussan Ley announced that Australia would become the first nation in the world to allow so-called “automatic” substitution of biosimilars by pharmacists in place of the biologic prescribed by a physician. This move came at the recommendation of Australia’s Pharmacy Benefits Advisory Committee (PBAC).

The proposal would make Australia the only first-world country to allow pharmacy-level substitution of biosimilars. The practice is opposed by both the European Medicines Agency and Health Canada, the global leaders in in biosimilar approvals, both of which leave the determination of which biologic medicine a patient receives solely to their physician.

The practice is explicitly banned in many countries including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland. While France statutorily permits automatic substitution in certain limited cases, this policy has never been implemented.

The U.S. Food and Drug Administration, which approved its first biosimilar in March, has not yet determined what safety and efficacy data it would require from a biosimilar’s sponsor in order to demonstrate that it could be safely substituted for its reference product.

Only Venezuela currently permits the practice.

Australian Government Resources

Australian Therapeutic Goods Administration (TGA) Guidelines on Evaluation of Biosimilars

Australian Health Minister announces that Australia will allow pharmacy-level substitution of biosimilars

Australian Pharmacy Benefits Advisory Committee (PBAC)

Australian Parliament Senate Economics Legislation Committee

Additional Resources:

Naming Onepager (Australia) REV Oct. 2016: aus-onepager-naming-final

Substitution Onepager (Australia) REV Oct. 2016: aus-onepager-substitution-fnle


In response to this policy announcement, ASBM and several of its members sent letters raising patient safety concerns to Minister Ley and other prominent officials in the Australian government, including the TGA, the PBAC, and the Senate Economics Committee in advance of its hearing on the matter.

ASBM Letter to Australian government

Global Colon Cancer Association (GCCA) letter to Australian government

International Cancer Advocacy Network letter to Australian government

Letter from Stephen Murby, patient advocate and ASBM Advisory Board member, to Australian government.

ASBM Surveys of Biologic Prescribers

Through a series of four surveys, ASBM has asked biologic-prescribing specialists in 11 countries what they think of pharmacy substitution:

  • 62% of the European physicians, 71% of the Canadian physicians and 85% of Latin American physicians consider a pharmacy-level determination of which biologic to dispense to their patient to be “unacceptable”.
  • Notification in the event of a biosimilar substitution was deemed “very important” or “critical” by 80% of U.S., 77% of European, 85% of Canadian, and 87% of Latin American physicians surveyed.
  • The ability to prevent a substitution by indicating “do not substitute” or “dispense as written” on the prescription was considered “very important” or “critical” 82% of U.S., 74% of European, 80% of Canadian, and 85% of Latin American physicians surveyed.

All ASBM surveys are available at

News Coverage

News coverage and analysis of the Australian substitution debate from PharmaDispatch (Australia): Presentation

“Understanding Biological and Biosimilar Medicines: The New Frontier”:
A powerpoint presentation on biosimilars presented to Medicines Australia in June 2015 by patient advocate and ASBM Advisory Board member Stephen Murby.