The PBAC made the decision that Brenzys be ‘a’ flagged at its July 2016 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 the Brenzys for its reference product, Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

The PBAC also endorsed switching between Enbrel and Brenzys, saying that ‘the drug, etanercept, is not immunogenic per se, and anti-drug antibodies are rare. Switching between brands of etanercept is unlikely to change this.’

The data used to support the PBAC’s decision included efficacy and safety data from phase III trials comparing Brenzys and Enbrel, as well as data from a phase III trial in treatment-naïve patients initiating on either Enbrel or Brenzys (SB4-G31-RA). This clinical evidence, according to the PBAC ‘suggested no difference in efficacy, safety or immunogenicity’.

The Advisory Committee on Prescription Medicines (ACPM) has therefore declared Brenzys a biosimilar for Enbrel. The ACPM was satisfied of the similar safety and efficacy of Brenzys and Enbrel in rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

The decision 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 [1].

Related articles
Australian approval for biosimilar insulin

Biosimilars approved in Australia

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Australia’s PBAC recommends substitution of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/General/Australia-s-PBAC-recommends-substitution-of-biosimilars

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 © 2016 Pro Pharma Communications International. All Rights Reserved.