Given the many demands on your time, the following resources have been developed utilising a flexible online format and are designed to facilitate peer-to-peer information exchange about biosimilar medicines – covering a range of speciality areas.

Also available are the following resources for download and print.

  • Prescriber Factsheet
  • Healthcare Professional Essentials

To ensure that available materials meet your and your patients’ needs, we invite you to submit your feedback via our dedicated ‘have your say’ area on the biosimilar hub.

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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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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Videos

Dr Michael Coory, Department of Health

Listen to Dr Michael Coory, Department of Health, as he discusses how price disclosure works for biosimilar medicines and how this contributes to the sustainability of the Australian healthcare system

Rheumatologist

Prof Bird has over twenty years’ experience in treating rheumatic disease, with particular expertise in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Oncologist

Prof Clarke is a medical oncologist, pharmacologist and translational researcher with major clinical and research interests in gastrointestinal and thoracic cancers.

Gastroenterologist

Dr Ghaly is Head of the Inflammatory Bowel Disease Service and Staff Specialist at St. Vincent’s Hospital, Sydney. He is also a lecturer at the School of Medicine, UNSW Sydney.

Rheumatologist

A/Prof Östör MD, MA, MB BS, FRACP, FRCP, FRCP (Edin), is a Consultant Rheumatologist at Cabrini Medical Centre and Principle Investigator at Emeritus Research, Melbourne.

Dermatologist

Prof Sinclair is Professor of Dermatology at the University of Melbourne and Director of Epworth Dermatology. He is past-president of the Australasian Society for Dermatology Research.

Haematologist

Prof Szer has particular expertise in malignant haematology and haemopoietic stem cell transplantation, which he established as a form of therapy in Victoria in the early 1980s.

Gastroenterologist

Dr Thin is a consultant gastroenterologist at Fiona Stanley Hospital, a position she has held for 8 years. Dr Thin is the lead clinical trials investigator for the IBD unit.

Oncologist

Prof Zalcberg is Head of the Cancer Research Program in the School of Public Health and Preventive Medicine at Monash University.
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