Biosimilars no longer eligible for parallel processing in Australia

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Biosimilars no longer eligible for parallel processing in Australia

INICIO/Políticas y legislación | Posted 05/10/2018 0 Post your comment

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.

Under parallel processing arrangements drug applications can be submitted to both Australia’s Therapeutic Goods Administration (TGA) for approval and to Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the country’s Pharmaceutical Benefits Scheme (PBS).

Once licensed by TGA, there is a system of cost subsidy for drugs, called the PBS, whose role is to balance cost and the contribution of an individual drug to an improved outcome for patients. Drugs are generally not widely prescribed in Australia before they are listed on the PBS [1].

To speed up the process of listing on the PBS sponsors can request a TGA–PBAC parallel process. This enables the respective registration and reimbursement evaluation and assessment processes for major submissions to be undertaken in parallel. However, according to a posting on the PBS website of 14 September 2018, biosimilars will no longer be able to request parallel processing until after the TGA has made a determination of biosimilarity, i.e. until after approval.

Related article
Biosimilars approved in Australia

Reference
1. Power DA. Licensing and prescribing biosimilars in Australia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):152-4. doi:10.5639/gabij.2014.0304.043

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Source: PBS