Australia has a robust regulatory system that ensures the safety, effectiveness and quality of all medicines. This includes chemical and generic medicines, and biological and biosimilar medicines. The regulatory system is managed by Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health. The regulatory system addresses every step in medicine production and use: As with all medicines in Australia, biosimilar medicines are rigorously evaluated by the TGA. For a biosimilar medicine to be registered in Australia, the reference biological medicine must be registered in Australia or a similarly regulated country, and it must be proved that the biosimilar medicine is highly similar to the reference biological medicine in terms of safety, effectiveness and quality. This is shown through laboratory, animal and human studies. The TGA has adopted international guidelines from the European Medicines Agency for the evaluation studies and data that are required. Once the TGA has approved a medicine, the pharmaceutical company may apply to the Pharmaceutical Benefits Advisory Committee (PBAC) to list their medicine on the Pharmaceutical Benefits Scheme (PBS). The PBS subsidises the costs of listed medicines to reduce the cost to patients. In deciding whether a medicine should be recommended for subsidy, the PBAC considers the patient benefits and cost-effectiveness of the medicine compared with alternative medicines. The PBAC will only recommend a biosimilar medicine for PBS listing if it is satisfied that it will deliver the same health outcomes as the reference biological medicine. Once a medicine is on the market, the TGA monitors its performance in terms of safety, effectiveness and quality. The TGA relies on consumers, health professionals and industry to report problems with medicines. The TGA investigates all reports of problems to determine whether it needs to take any action. The TGA has several options if there may be a risk to patients from any medicine. It can: The TGA also monitors the medicine to make sure the molecules are being produced consistently by the manufacturer, and not changing over time. The TGA sends out alerts and media articles to ensure that health professionals and the public are aware of any safety concerns and changes to the availability and recommended use of all medicines in Australia. Key points