Australia’s PBAC recommends substitution of adalimumab biosimilars

Biosimilars/News | Posted 08/02/2019 post-comment0 Post your comment

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).

Substitution V13F14

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

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010