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Demystifying bioequivalence

Lynn M Weekes
Med J Aust 2014; 201 (4): 188. || doi: 10.5694/mja14.00904
Published online: 18 August 2014

Doctors are key to helping patients understand any real or perceived differences between different brands of medicines, but confusion still abounds among health professionals and consumers when it comes to choosing between alternative (or generic) brands of medicines.

The availability of alternative brands can lead to cost savings in the health system, and alternative brands represent an important choice for patients. Much of our work in this area over the past few years has been designed to improve health literacy and understanding about active ingredients in a marketplace where both innovator and generic brands of medicines are available, and to support safe and effective use of these medicines.

It is fair to say that there remains a perception that alternative brands are somehow inferior. While consumer confidence has increased over the past few years, there are still occasionally media reports or comments from prominent health professionals supporting a view that generics are of a lower standard.

The reality in Australia is that for generic medicines to be established as bioequivalent they must meet stringent standards for quality, and they are only approved by the Therapeutic Goods Administration if these standards are met.

NPS MedicineWise recently launched a freely available e-learning program, Demystifying bioequivalence (http://learn.nps.org.au). Produced for health undergraduates and practising health professionals, it addresses scientific and clinical questions about bioequivalence, explaining how alternative medicines are established as bioequivalent and approved for the Australian market. It is designed to help doctors support patients to understand why they might be offered a choice of medicines, and to answer questions that patients may have about medicine quality. The program debunks some of the myths that exist around bioequivalence and explores questions of the safety and effectiveness of alternative brands.

Bioequivalence is an area of great uncertainty. This program is designed to provide health professionals with a greater level of confidence and understanding.

  • Lynn M Weekes

  • NPS MedicineWise

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