Industry Trend Analysis - Approval Summary Is First Step In Increasing Australian Generic Drug Utilisation - SEPT 2017


BMI View: In releasing the first annual summary of generic and biosimilar prescription medicine approvals, Australia's TGA is highlighting an increased focus on promoting the use of generics to lower pharmaceutical spending costs. The Australian Government has committed itself to promoting generic usage, with an aim of matching prescription levels seen in the US and the UK. Outlining new approvals will help reach this aim, but levels in the US are boosted by the competition encouragement fostered by the Hatch-Waxman Act. Without similar legislation in Australia, prescription levels are unlikely to achieve the Government's goal.

Australia's Therapeutic Goods Administration (TGA) has released an annual summary of generic and biosimilar prescription medicines for 2016. According to the report, 114 submissions in 2016 resulted in the registration of new generic medicines in the Australian Register of Therapeutic Goods. These submissions involved 73 discrete active ingredients across a range of therapeutic areas. This is the first publicly available annual summary of all new generic and biosimilar prescription medicines registered in Australia, and complements other summaries published by the TGA on the registration of new chemical entities.

Of the generic prescription medicines registered in 2016, 20 submissions resulted in the registration of first-time generic versions. The listing of a first generic version of a medicine by the Department of Health triggers a statutory price reduction of 16% under the Pharmaceutical Benefits Scheme (PBS).

Low-Cost Drugs Need To Be A Focus Of Cost-Containment
Australia: Generic Drug Spending (AUDbn)
f=forecast. Source: National Sources/BMI

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