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Australia’s PBAC recommends substitution of adalimumab biosimilars Posted 08/02/2019

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).

The PBAC made the decision that Amgevita and Hadlima be ‘a’ flagged at its July 2018 meeting. Medicines deemed substitutable at the pharmacy level by the PBAC include a notation in the official Pharmaceutical Benefits Schedule known as an ‘a’ flag. The decision gives pharmacists the authority to substitute Amgevita and Hadlima for their reference product, AbbVie’s arthritis blockbuster Humira (adalimumab).

The PBAC also advised that the biosimilar uptake drivers should be applied to adalimumab. Australia has implemented two specific biosimilar uptake drivers [1]:

• encouraging prescribing of a biosimilar brand rather than the reference biological brand for treatment naïve patients
• providing for a simpler and faster approval process for prescribing biosimilar brands, e.g. streamlined authority, while maintaining an existing higher level authority requirement for the reference biological brand, e.g. written authority.

The decision on Amgevita and Hadlima is in line with the PBAC’s position on the substitution of biosimilars. The committee has previously said that the absence of significant differences in safety and efficacy, along with data in treatment-naïve patients and data to support switching would support ‘a’ flagging of a biosimilar [2].

The PBAC made a similar decision with respect to the etanercept biosimilar Brenzys back in July 2016. The committee also said that the biosimilar could be substituted at the pharmacy level for its reference product, Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) [3].

Related article
Biosimilars approved in Australia

References
1. GaBI Online - Generics and Biosimilars Initiative. Australia encouraging biosimilars and mandating drug shortage reporting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from:www.gabionline.net/Policies-Legislation/Australia-encouraging-biosimilars-and-mandating-drug-shortage-reporting
2. GaBI Online - Generics and Biosimilars Initiative. Australia’s PBAC recommends substitution of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Biosimilars/General/Australia-s-PBAC-recommends-substitution-of-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Australia says etanercept biosimilar can be substituted [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 8]. Available from: www.gabionline.net/Biosimilars/News/Australia-says-etanercept-biosimilar-can-be-substituted

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