How are biosimilar medicines regulated and monitored?

Page last updated: 23 March 2017

Graphic outlining that all medicines in Australia are assessed and regulated by the Therapeutic Goods Administration. It provides oversight to the whole process after a medicine is developed – it assesses the evidence, registers the medicine, monitors the medicine once people are using it, reviews any adverse events or changes, and enforces manufacturers to comply with manufacturing standards.

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:

  • Before any medicines (including biological and biosimilar medicines) are allowed onto the market, they undergo rigorous testing and evaluation. These tests must show that the medicines are safe and that they benefit patients.
  • Data from analytical, laboratory and clinical studies are evaluated at the TGA by a team of doctors, health professionals, scientists and consumer representatives. Once the TGA is satisfied that the benefits to patients outweigh any risks, the medicine can be registered for use in Australia.
  • Medicine manufacturers must comply with a range of standards that ensure product safety, quality and consistency.
  • Medicines that are on the market are monitored to ensure that there are no adverse effects or side effects in patients. Any adverse effects are investigated, and the medicine may be taken off the market if the risk to patients is too high.

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:

  • require changes to product labelling, such as added warnings
  • limit the types of patients that can take the medicine
  • require the pharmaceutical company to do more research
  • take the medicine off the market.

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.

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