At a glance
A biosimilar medicine is highly similar to a ‘reference biological medicine’. The reference biological medicine is the first brand to market. Biological and biosimilar medicines contain substances that are made by living cells or organisms.
Biological medicines, including biosimilars, are used to treat serious diseases such as rheumatoid arthritis, inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease, cancer, diabetes, multiple sclerosis, kidney disease and severe psoriasis, and for treating infertility.
The introduction of biosimilar medicines encourages competition in our Australian market. This will lead to a reduction in the cost of medicines, resulting in savings to the health care system.
These lower prices improve affordability and access to new treatments for seriously ill patients.
Biosimilar medicines are tested in Australia. They are checked for safety and to confirm they provide the same health outcomes as the reference biological medicine.
Biosimilar medicines have been used for over 10 years. They are now used in over 60 countries. Lower costs and increased access to medicines has been demonstrated internationally. This shows promise for Australia.
Biosimilar Education
As part of the 2017 budget process the Government agreed to continue its investment in educating prescribers, pharmacists and consumers on the benefits of using biosimilar medicines through supporting the GBMA with a grant to undertake activities to further promote the appropriate prescribing, dispensing and use of biosimilar medicines.
A grant was awarded to GBMA Education Limited in April 2018 to undertake activities to complement and extend the Department’s Biosimilar Awareness Initiative. The total value of the grant is $5 million, with activities under the grant to be completed by December 2020.
Details about the purpose, activities and arrangements for the grant are set out in the Biosimilar Education Grant Opportunity Guidelines:
- Biosimilar Education Grant Opportunity Guidelines - (PDF 504 KB)
- Biosimilar Education Grant Opportunity Guidelines - (Word 55 KB)
Further information is available at the GBMA Education website.
This webpage provides information published by the Department of Health as part of the Biosimilar Awareness Initiative. The Department will continue to publish information supporting biosimilar awareness, including:
- a list of biological medicines on the PBS and biosimilars that are TGA registered and PBS listed;
- information about new PBS listed biosimilars and the application of uptake drivers for biosimilars.
Biosimilar medicines Information
Biological medicines currently listed on the Pharmaceutical Benefits Schedule (PBS) can be found on the PBS website.
Biosimilar medicines currently listed on the Pharmaceutical Benefits Schedule (PBS) and approved by the Therapeutic Goods Administration (TGA) are available at 'Which biosimilar medicines are available in Australia?'.
Printable resources
Biosimilar trastuzumab
Biosimilar etanercept
Biosimilar infliximab
Biosimilar Uptake Drivers
The Australian Government is implementing two specific drivers to encourage the use of biosimilar medicines, which will complement the Biosimilar Awareness Initiative.
Information about the uptake drivers can be found on the Biosimilars on the PBS web page.
National Medicines Policy
The Australian Government is a key partner in the National Medicines Policy which supports four central objectives of:
- timely access to the medicines that Australians need, at a cost individuals and the community can afford;
- medicines meeting appropriate standards of quality, safety and efficacy;
- quality use of medicines; and
- maintaining a responsible and viable medicines industry.
Biosimilar medicines represent a means to further the objectives of the National Medicines Policy, by enhancing access to medicines and by maintaining a competitive market. These objectives also align with the World Health Organization’s definition of the rational use of medicines.