Biosimilars no longer eligible for parallel processing in Australia

Home/Policies & Legislation | Posted 05/10/2018 post-comment0 Post your comment

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

Substitution V13F14

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: PBS

comment icon Comments (0)
Post your comment
Related content
FDA publishes final Q&A on biosimilar development and the BPCI Act
Question-Fimea-V15E29
Home/Policies & Legislation Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
Home/Policies & Legislation Posted 08/10/2021
USA BIOSIM Act introduction
02 AA010638
Home/Policies & Legislation Posted 17/09/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010