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Updated April 2023
A biosimilar medication is a highly similar (but not identical) version of an original biological medication. There is no meaningful difference in its safety, quality and effectiveness compared to the original biological medications. All biosimilar medications must be approved by the TGA after analysis of data regarding their safety, quality, consistency and effectiveness.
Biological medications contain substances that are made by living cells or organisms. They have revolutionised treatment of variety of conditions including rheumatoid arthritis, inflammatory bowel diseases, cancer, diabetes, multiple sclerosis, kidney disease and severe psoriasis.
No. A generic brand of medication is an identical copy of the original medication. Biosimilar medications are not referred to as generic medications because the process that produces biological medications are naturally variable. No two batches of a biological medications are ever exactly the same.
The use of biosimilar medications can improve the health care for all Australians.
Biological medications are high-cost medications costing the federal government billions of dollars each year. Introducing biosimilar medications into the market (once the original biological medication goes off patent) increases market competition and drives down prices thereby making these life changing medicines more affordable and accessible for the benefit of Australian patients.
Biosimilar medications give patients access to more brand options and can reduce the risk of medication shortages.
Compared with the original biological medication, a biosimilar medication:
Sometimes biological medications and their biosimilars use a different type of injection pen or syringe and you may need to learn to use a new type of device. Talk to your doctor or pharmacist to understand any differences in the way you will use the medication.
Generally biosimilar medications can be used whether or not you have been treated with an original biological medication first. Always talk to your treating specialist about available treatment options including the risks and benefits of switching to a biosimilar medication.
You can refer to detailed information for consumers on the Biosimilar Awareness Initiative webpage at www.health.gov.au/biosimilars You can also discuss any further questions you have about biosimilar medicines with your health care provider.