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Updated March 2025
A biosimilar medicine is a highly similar (but not identical) version of an original biological medicine. There is no meaningful difference in its safety, quality and effectiveness compared to the original biological medicines. All biosimilar medicines must be approved by the TGA after analysis of data regarding their safety, quality, consistency and effectiveness.
You can find more information on 'Changing brands of biologics' here.
Biological medicines contain substances that are made by living cells or organisms. They have completely changed treatment for conditions like rheumatoid arthritis, inflammatory bowel diseases, cancer, diabetes, multiple sclerosis, kidney disease and severe psoriasis.
No. A generic brand of medicine is an identical copy of the original medicine. Biosimilar medicines are not referred to as generic medicines because the process that produces biological medicines are naturally variable. No two batches of a biological medicine are ever exactly the same, even when produced by the same manufacturer.
The use of biosimilar medicines can improve the health care for all Australians.
Biological medicines are high-cost medicines costing the federal government billions of dollars each year. Introducing biosimilar medicines into the market (once the original biological medicine 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 medicines give patients access to more brand options and can reduce the risk of medicine shortages.
Compared with the original biological medicine, a biosimilar medicine has:
Sometimes biological medicines 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 medicine.
Generally biosimilar medicines can be used whether or not you have been treated with an original biological medicine first. Always talk to your treating specialist about available treatment options including the risks and benefits of switching to a biosimilar medicine.
You can refer to more information in the following resources:
You can also discuss any further questions you have about biosimilar medicines with your healthcare provider.