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Generic Facts and Fallacies

Generic Medicines = Quality and Affordability

Generic medicines have been available in Australia for almost 50 years, and widely supplied through the Pharmaceutical Benefits Scheme for over 30 years, delivering the same health benefits as the original brands at a lower cost to government and the community. 


Through monitoring generic medicine use over this time, their role as safe & effective treatment options has been confirmed.

Facts

A generic medicine is simply another brand, which contains the same active ingredient as the original brand
Generic medicines have the same quality as the original brand and must meet the same TGA standards of safety and equivalence to the original brand.
Generic medicines, and their sites of manufacture, are thoroughly evaluated and approved by the Government before they can be sold
The manufacturer of a generic medicine must meet strict production and quality assurance standards set by TGA. The performance of a generic medicine is then continually monitored once it becomes available to consumers.
Generic medicines can contain different fillers and colours
Fillers and colours are only changed to take advantage of newer or safer ingredients or to ensure the generic medicine delivers the active ingredient in a manner equivalent to the brand medicine. The list of TGA approved fillers and colours that can be used to manufacture any medicine is relatively small, so similar ingredients are generally used in both the generic medicines and original brands.
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Fallacies and Common Misconceptions

A generic medicine may not work as well as the original brand
All quality studies applied to the original brand must also be performed on the generic medicine. Some human trials testing safety and efficacy do not have to be repeated because the TGA accepts that the same outcomes will be shared by the generic medicine and original brand.
Generic medicines are less expensive because they contain less active ingredient, cheap fillers or meet lower standards
Generic medicines must use fillers and colours that are approved by the TGA for medicine manufacture, and deliver the same amount of active ingredient to the body in the same way as the original brand
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REFERENCES
1. U.S. Food and Drug Administration. Generic drugs: questions and answers. August 2011. Link
2. Therapeutic Goods Administration. Australian regulatory guidelines for prescription medicines. June 2004. Link
3. The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods, Version 4.0, September 2011. Link
4.McLachlan AJ, Ramzan I, Milne RW, Frequently asked questions about generic medicines. Australian Prescriber 2007; 30: 41-43
5. Pearce GA, McLachlan AJ, Ramzan I, Bioequivalence: how, why and what does it really mean? Journal of Pharmacy Practice and Research 2004; 34: 195-200
6.Davit BM, Nwakama PE, Buehler GJ et al Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration. The Annals of Pharmacotherapy 2009; 43: 1583-1597

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