Australia’s PBAC recommends unrestricted benefit listing for rituximab biosimilars

Biosimilars/News | Posted 19/11/2021 post-comment0 Post your comment

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.

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At its meeting in September 2021, the PBAC recommended removal of the administrative notes related to the biosimilar uptake drivers for rituximab, in light of the removal of the reference brand of rituximab, MabThera, from the PBS.

The PBAC recommended that the PBS listings for all listed brands of rituximab (including the biosimilars Riximyo and Truxima) be changed to ‘Unrestricted Benefit listings’.

This change in the rituximab listings to unrestricted is expected to provide subsidized access to treatment for patients with conditions where there are no alternative PBS-listed medicines. The committee also considered that the expanded use of the Riximyo and Truxima biosimilars would be cost effective, given the price reductions to rituximab to date and scheduled from 1 October 2021.

Sandoz gained approval from Australia’s Therapeutic Goods Administration (TGA) for its rituximab biosimilar, Rixymio (GP2013), in November 2017. While Celltrion gained approval from the TGA for its rituximab biosimilar, Truxima (TL011), in April 2018 [1].

This change to the PBS listings comes in the wake of the announcement in September 2021 that the Australian Government had entered into five-year strategic agreements with Medicines Australia and the Generics and Biosimilar Medicines Association (GBMA), to improve access to affordable, innovative, and life-saving therapies, vaccines and medicines [2].

Source: PBAC, Sandoz

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. New five-year medicines agreements in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 19]. Available from:

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