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 of, 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.
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?'.
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.
Biosimilar Awareness Initiative Project Management Plan
The purpose of the Project Management Plan is to provide a framework for the project and to guide the progress of the Initiative over the three year term. As part of the project governance, the Department established a Steering Committee and a Stakeholder Reference Group. Both the Steering Committee and the Reference Group have been consulted regarding the Project Management Plan.
The Plan will be used to inform the longer term development and implementation of the awareness project.
You can access a copy of the Project Management Plan here: