Generic and biosimilar medicines play an important role in helping Australians access the medicines they need. Find answers to common questions about generic and biosimilar medicines, medicine supply, the Pharmaceutical Benefits Scheme and Australia’s medicines system.
Generic medicines
What is a generic medicine?
A generic medicine is an additional brand of an existing medicine that contains the same active ingredient and is designed to have the same therapeutic effect.
Before a generic prescription medicine can be supplied in Australia, it must meet the requirements of the Therapeutic Goods Administration (TGA). This includes demonstrating appropriate quality and, where required, bioequivalence to the reference medicine – meaning the active ingredient is absorbed by the body at a similar rate and to a similar extent.
Generic medicines create competition once relevant exclusivity protections have ended, helping to support affordable and accessible medicine supply.
Are generic medicines as safe and effective as the original brand?
Yes. Generic prescription medicines supplied in Australia must meet the Therapeutic Goods Administration’s requirements for quality, safety and efficacy.
A generic medicine contains the same active ingredient as its reference medicine and, where required, must demonstrate bioequivalence. While its appearance, packaging or inactive ingredients may differ, it is required to meet Australian regulatory standards before it can be supplied to patients.
If you have questions about changing between medicine brands, speak with your doctor or pharmacist.
Biosimilar Medicines
What is a biosimilar medicine?
A biosimilar is a biological medicine that has been demonstrated to be highly similar to an already approved biological medicine, known as the reference medicine.
Biological medicines are large and complex medicines made using living systems. Because of this complexity, biosimilars are not described as exact copies. Instead, extensive comparisons are used to demonstrate that there are no clinically meaningful differences between the biosimilar and its reference medicine in quality, safety and effectiveness.
In Australia, biosimilar medicines are evaluated by the Therapeutic Goods Administration before they can be supplied.
Are biosimilar medicines safe and effective?
Yes. Biosimilar medicines approved in Australia must meet the Therapeutic Goods Administration’s rigorous requirements for quality, safety and effectiveness.
Approval requires extensive evidence demonstrating that a biosimilar is highly similar to its reference biological medicine and that there are no clinically meaningful differences in how the medicines perform.
Biosimilars have been used in Australia and internationally across a range of serious and chronic health conditions.
Patients with questions about their individual treatment should speak with their healthcare professional.
What is the difference between a generic medicine and a biosimilar medicine?
Generic and biosimilar medicines are developed and assessed differently because the medicines themselves are different.
Generic medicines are generally versions of smaller, chemically manufactured medicines and contain the same active ingredient as their reference medicine.
Biosimilars are versions of much larger and more complex biological medicines made using living systems. A biosimilar must be demonstrated through extensive comparative evidence to be highly similar to its reference medicine, with no clinically meaningful differences in quality, safety or effectiveness.
Both must meet Australian regulatory requirements before they can be supplied to patients.
Medicine shortages and supply resilience
Why is Australia vulnerable to global medicine supply disruptions?
Australia imports more than 90 per cent of the prescription medicines used in the country, making access heavily dependent on international manufacturing and supply chains.
Australia is also geographically distant from many global manufacturing centres and represents a relatively small market compared with larger countries and regions. When worldwide supply is constrained, countries can be competing for access to the same limited medicine supply.
Australia cannot prevent every global disruption, but strong domestic policy, regulatory and supply settings can reduce the likelihood that a global problem becomes a medicine shortage for Australian patients.
How do generic and biosimilar medicines strengthen medicine supply?
A sustainable generic and biosimilar medicines market can strengthen supply by supporting competition and reducing reliance on a single supplier.
Where several viable suppliers are able to participate in the Australian market, the health system may have more options if one manufacturer experiences a production or supply disruption.
However, simply having multiple registered products is not enough. Suppliers must also be able to maintain commercially sustainable and reliable supply over the long term. This is why competition, medicine pricing and supply resilience need to be considered together.
What has GBMA proposed to improve medicine supply resilience in Australia?
GBMA has called for Australia to move beyond managing medicine shortages only after they occur and place greater emphasis on preventing avoidable shortages from reaching patients.
In its 2026 White Paper, No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience, GBMA proposed action across three connected areas:
- strengthening the long-term sustainability of the medicines market;
- improving the early identification, coordination and communication of medicine shortages; and
- streamlining regulatory processes without lowering Australia’s standards for medicine quality, safety or effectiveness.
The reforms are designed to complement Australia’s existing shortage-management arrangements and strengthen the country’s ability to withstand global supply disruption.
Read more: No Patient Left Waiting: A Reform Roadmap for Medicine Supply Resilience
GBMA
What is the Generic and Biosimilar Medicines Association (GBMA)?
The Generic and Biosimilar Medicines Association (GBMA) is the peak representative body for generic and biosimilar medicine suppliers in Australia.
GBMA works with government, regulators, healthcare organisations, patient groups and other stakeholders to support timely and reliable access to high-quality generic and biosimilar medicines.
Its policy and advocacy work focuses on a sustainable medicines market, stronger medicine supply resilience, efficient regulation and ensuring Australia captures the patient and health-system benefits of generic and biosimilar competition.
GBMA’s purpose is making medicines accessible.