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Education

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

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.
How similar is Biosimilar?
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,
Development of biological medicines
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.
Development of biosimilar medicines
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.
Reassurance of similarity
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.
Regulatory framework
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.
Approval of biological medicines
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.

Resources

Prescriber Factsheet
Information on biosimilar medicines
This 6 page factsheet provides prescribers with information on biosimilar medicines.
Pharmacist Factsheet
Information on biosimilar medicines
This 6 page factsheet provides pharmacists with information on biosimilar medicines.
Consumer/carer Factsheet
Information on biosimilar medicines
This factsheet provides consumers and carers with information on biosimilar medicines.
Healthcare professionals Essentials A4
Essential information on biosimilar medicines
This document provides healthcare professionals with the essentials on biosimilar medicines.
Consumer/carer Essentials A4
Essential information on biosimilar medicines
This document provides consumers and carers with the essentials on biosimilar medicines.
Healthcare professional Essentials DL
Essential information on biosimilar medicines
This DL sized brochure has been designed to wrap around other leaflets, brochures or folders.
Patient letter template
Supporting documentation to inform patients of a switch to a biosimilar medicine
A letter template that you may wish to use to inform patients of a brand change.

Courses

Accredited CPD activity for specialists on biosimilar medicines
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Accredited CPD activity for pharmacists on biosimilar medicines
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Accredited CPD activity for prescribers on biosimilar medicines
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