PBAC Decision to Approve Biosimilars for Pharmacy Substitution is a Safety Concern for Patients

Medicines Australia notes with concern the recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) that pharmacists be allowed to substitute biosimilars in place of biologic medicines prescribed by a patient’s doctor.

The so-called “a-flagging” means that pharmacists can make this substitution without the knowledge or consent of the patient’s specialist doctor, GP or even the patient.

This decision by the PBAC announced today, goes against all the advice they have received from international and local experts that there is an absence of an agreed evidence base to support the safety and efficacy of repeated, or multiple, switching between a biologic and one or more biosimilar medicines.

Medicines Australia absolutely affirms the safety and efficacy of biosimilars that have undergone a thorough assessment by the expert Therapeutic Goods Administration. This is not in question.

Biosimilars can treat the same condition as the reference original biologic, but they can and do have a range of variations which may or may not have an adverse impact on patients. Biologic medicines are not generic medicines.

Therefore, it is critical that a patient’s doctor is involved in any decision to move a patient from one biologic or biosimilar medicine to another and they need a strong evidence base to rely upon to make that decision.

Medicines Australia represents the majority of companies that are developing biosimilar medicines for the Australian market. We strongly support the introduction and uptake of biosimilar medicines but this must be done appropriately and based on reliable evidence to build public confidence in their quality use. This will ensure that biosimilars can make a significant contribution to the health of Australians and the sustainability of the Pharmaceutical Benefits Scheme (PBS) well into the future.

The medical and patient community need confidence that the Australian Government and its appointed advisory bodies are making the right decisions in the interests of their health and safety and not based on the Governments own bottom line savings targets.

Medicines Australia strongly urges the Government to begin a formal process of consultation with all relevant stakeholders, including patient groups and doctors to develop a comprehensive biosimilars policy, based on evidence, and including appropriate education, which puts patient safety first.


James Boyce
Phone: 0423 239 265

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au