Australia says etanercept biosimilar can be substituted

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Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be marked as equivalent’ to the brand-name biological Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).

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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].

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

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