GBMA Education would like to acknowledge and extend their thanks to the members of the Biosimilar Education Stakeholder Group (BESG) – which includes representatives from across medical, pharmacy, medicines industry, consumer advocates and the Department of Health – for their collaboration and support in the development of the educational materials for the Biosimilar Hub. 

Information on biosimilar medicines

a highly similar version of an already registered biological medicine

Biological medicines are pharmaceutical products that contain one or more active substances that are derived from living cells or organisms.

Demonstrating high similarity is the foundation of development

As biosimilar medicines are designed and engineered using the latest technology to resemble their reference product as closely as possible,

BIOLOGICAL MEDICINES ARE MEDICINES THAT ARE MADE BY LIVING CELLS OR ORGANISMS

Biological medicines are medicines that are made by living cells or organisms. They are usually made of large proteins that are naturally produced in the human body.

Biosimilar medicines are used to treat the same diseases in the same way

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

The aim of the clinical program is to confirm therapeutic equivalence

Biosimilar medicines are required to undergo a tailored clinical program. This is normally a stepwise process, beginning with pharmacokinetic/ pharmacodynamic (PK/PD) studies.

The TGA approved its first biosimilar medicine in 2010

More than a decade of international real-world experience and associated post-marketing data has found no difference in the safety or health outcomes of patients.

Australia has a strong regulatory system for all medicines

Australia has a strong regulatory system that ensures the safety, effectiveness and quality of all medicines, including biological medicines.
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Resources

Subsidised on the PBS

A list of all biosimilar brands of biological medicines that are subsidised on the Pharmaceutical Benefits Scheme (PBS) in Australia.
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