Understanding biosimilars

If you use a biological medicine to treat or keep a chronic condition under control, then you may have heard your doctor mention a group of medicines called biosimilars. Read on to learn more about these medicines.


What is a biosimilar?

A biosimilar is a medicine that is a very close, but not identical, copy of an original biological medicine. The first biosimilar medicine was approved in Australia in 2010.

Biological medicines and their biosimilars are usually made from the cells of living organisms – many of these medicines are made from proteins that are naturally produced by the human body. You might also hear these medicines called biologics or biologicals.

Making biological medicines is more complicated than more conventional types of medicines because they are made inside living cells rather than through a standard chemical process.

A biosimilar works in the same way as the original biological medicine and is available once the patent on the original biological brand expires.

The biological medicine and its biosimilar have the same active ingredient (the ingredient that makes the medicine work) but will have different brand names devised by their manufacturers.

Learn more about active ingredient prescribing

What is the difference between a biological medicine and its biosimilar?

A biosimilar is a highly similar version of an already approved brand of biological medicine. Due to the complex process of making biological medicines, it is impossible to create an exact copy of the original biological medicine.

Although they are not identical, there are no major differences in the ways that biological medicines and their biosimilars work.

The Therapeutic Goods Administration (TGA) is responsible for approving medicine. The TGA looks at all of the evidence provided by pharmaceutical companies to show that a new biosimilar works in the same way as the original biological medicine.

The evidence must show that there are no differences in effect, safety and the way it works in the body between the biosimilar and its original biological medicine. A biosimilar can only be marketed in Australia when the TGA agrees it has been shown to be as safe and effective as the original biological medicine.

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.

Are biosimilars the same as generic brands?

No. A generic brand of medicine is an identical copy of the original medicine. The active ingredients in non-biological medicines have simpler structures and it is possible to make exact copies of these medicines.

Biosimilars are not like generic brands of medicines because they are not completely identical to the original biological medicine.

What conditions is this type of medicine suitable for?

Biological medicines and their biosimilars are used to treat and manage the same conditions. Treatment areas where biosimilars are currently available include:

  • inflammatory arthritis such as rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis)
  • inflammatory bowel diseases such as ulcerative colitis and Crohn disease
  • severe psoriasis
  • cancer
  • diabetes
  • multiple sclerosis
  • kidney disease.

Are there benefits to using a biosimilar medicine compared to the original biological medicine?

If you are taking a biological medicine and there is a biosimilar available, you will have the same health benefits from both types of medicines.

Under the Pharmaceutical Benefits Scheme, a biosimilar will also cost you the same amount as the original biological medicine.

The main benefit of biosimilar medicines is their potential to create cost savings for the healthcare system by encouraging competition between medicine manufacturers. This drives the price of the biological medicines down, making them more affordable for the Australian government to subsidise. These cost savings can then be used to subsidise more medicines or provide more people with access to treatments.

How do I know if I can use a biosimilar instead of the biological medicine I currently use?

The best way to find out about which brand is best for you is to speak to the doctor who prescribes your biological medicine.

The Department of Health decides whether brand changes are allowed for each individual biological medicine and its biosimilars, based on the evidence provided by the pharmaceutical company. They must be satisfied that the effectiveness and safety of the biological medicine is not affected by changing between brands.

Can my pharmacist change which brand of biological medicine I use?

If more than one brand of your biological medicine is available and the Department of Health has determined they are equally safe and effective, your pharmacist can offer you a choice of brands.

However not all biological medicines and their biosimilars are approved for brand substitution by your pharmacist.

Your doctor may prescribe a specific brand of biological medicine because they believe it is the one that best meets your individual needs. This is especially important if your disease is not in remission or well controlled. If your doctor decides they want you to have a specific brand, they will need to add the brand name and tick the ‘Brand substitution not permitted’ box on your prescription.

Together with your doctor, understand which brand of biological medicine or biosimilar is right for you and know the name of both the active ingredient and brand of medicine you are using. A medicines list on paper or in your phone can be a useful way to keep all the information about your medicines together.

Download or print the NPS MedicineWise medicines list or download the MedicineWise app for your smartphone.

What questions should I ask my doctor or pharmacist?

Here are some questions that might be helpful when you are talking to your doctor or pharmacist about biosimilars:

  • Is changing to a biosimilar an option for me?
  • Will I need extra monitoring or tests when I first start using a biosimilar?
  • What happens if the biosimilar doesn’t work for me? Can I go back to the original biological medicine I was using?
  • Is the biosimilar given in the same way as my current biological medicine or does it use a different injection pen or device? Are there any special storage requirements or new equipment I’ll need?
  • Will I be using the same dosage as my current biological medicine?
  • What should I say if my pharmacist asks if I would like to change to a different brand of biological medicine?

Where can I find more information?

Speak to your prescribing doctor about the treatments available for your condition.

The Department of Health has many useful resources available on its Biosimilar Awareness Initiative website.