FAQs

Biological medicines are highly sophisticated medicines made from living cells or organisms (like bacteria and yeast).

To understand how biological medicines differ from other medicines, it helps to compare them to more common medicines that you may be familiar with, those made by chemical processes.

	Chemical medicines	Biological medicines
Example	Aspirin	Infliximab
What do they look like under a microscope?	Small and simple, made up of 21 atoms	Very large and highly complex, made up of more than 20,000 atoms
How are they made?	Simple chemical process	Complex biological process using the latest technology to modify the genes to produce the active ingredients for the medicine
How do you take them?	Commonly taken as pills	Cannot be made into a pill and are given as an injection or infusion instead
Can we make copies?	Yes, the active ingredient will be 100% identical across all batches	No, we cannot make identical copies of biological medicines. It’s normal to find minor differences between batches of the same biological medicine
What are new brands of the same medicine called?	Generic medicine	Biosimilar medicines

Yes. All biological medicines are thoroughly tested and must meet the strict standards of the Therapeutic Goods Administration (TGA) for quality, safety and effectiveness.

A biosimilar medicine is a highly similar version of an original brand of a biological medicine, marketed by a different manufacturer once the patent on the original brand expires.

Biosimilar medicines have been used since 2006, with Europe being the first region to approve them. Their use has steadily increased over time and they are currently available in more than 60 countries around the world. Biosimilar medicines have been available in Australia since 2010, where they’ve helped improve the lives of thousands of Australians with serious diseases such as cancer, rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, multiple sclerosis and kidney disease.

No, generic medicines are identical to the original brand because they are produced by chemical processes. A biosimilar medicine is a highly similar version of an original brand of a biological medicine. This is because – just like in nature, where no two things are ever identical copies – there are natural differences between all biological medicines.

Yes. To be available in Australia, all biosimilar medicines are thoroughly tested and must meet the high standards of the Therapeutic Goods Administration (TGA). This ensures that they meet the same strict standards for quality, safety and effectiveness as the original brand. Any minor differences between the original and the biosimilar medicine have been shown to have no difference for the person who requires the medicine (i.e. no difference in safety or effectiveness).

If your doctor doesn’t specify the brand of biological medicine on your prescription, then your pharmacist is able to offer you an alternative brand. The pharmacist must explain this to you and ensure that you’re happy with the change. At the end of the day, it’s up to you and your doctor to decide which brand of biological medicine is right for you.

There may be differences in how the device works between brands of biological medicines that you administer yourself i.e. the pen or auto-injector. It’s essential that your healthcare team show you how your new device works. Be sure to ask if you have any questions or concerns.

This depends on your hospital. Some hospitals have decided to hold only one brand of a biological medicine – this may be the original brand or the biosimilar brand for that medicine – while other hospitals may offer multiple brands. Be sure to discuss any questions with your healthcare team.

In Australia, we benefit from a world class healthcare system where the Government ensures medicines and health services remain affordable to those who need them. For example, under the Pharmaceutical Benefit Scheme (PBS), a medicine that costs $1,000 will only cost $40.30 (or $6.50 for concession) at the pharmacy. With the increasing availability of biological medicines for more diseases, the Government is spending a significant portion of the medicines budget on keeping biological medicines affordable for those who need them.

The availability of biosimilar medicines contributes to the sustainability of the Australian healthcare system by increasing competition between brands of the same biological medicine, leading to reduced overall costs for the healthcare system. By reducing the cost of healthcare services, the Government can invest in new medicines and offer better treatments to more people who need them, ensuring Australians receive world class healthcare today and in the future.

The savings from biosimilar medicines are felt by Australia as a whole through cost savings for the public healthcare system. You pay the standard PBS co-payment whether you receive the original or the biosimilar brand of biological medicine (i.e. $40.30 or $6.50 for concession).

You will experience the same safety and effectiveness from your biological medicine whether you receive the original brand or the biosimilar brand. The benefits of biosimilar medicines are for the wider Australian population and future generations through cost savings for the public healthcare system.

Your healthcare team is always your best source of information as they understand your individual needs. Don’t hesitate to ask them if you have any questions or concerns.

For information on a specific biological medicine, you can access the Consumer Information Leaflets on the TGA website here.

Our Useful Links page lists additional websites that we hope you find useful.