Australia’s PBAC recommends substitution of biosimilars

Biosimilars/General | Posted 19/06/2015 post-comment1 Post your comment

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level.

Substitution V13F14

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 PBAC, at its April 2015 meeting, recommended marking biosimilars as equivalent, i.e. ‘a’ flagging, and therefore suitable for substitution at the pharmacy level, where the data are supportive of this conclusion.

The PBAC advised that the following would be relevant considerations in establishing that a biosimilar could be ‘a’ flagged with the originator biological:

  • Absence of data to suggest significant differences in clinical effectiveness or safety compared with the originator
  • Absence of identified populations where the risks of using the biosimilar are disproportionately high
  • Availability of data to support switching between the originator and the biosimilar
  • Availability of data for treatment-naïve patients initiating on the biosimilar
  • Whether the Therapeutic Goods Administration has deemed a product to be biosimilar with the originator biological.

The PBAC also stated that where a biosimilar could not be ‘a’ flagged at the time of listing in the Pharmaceutical Benefits Scheme (PBS), data should be collected to support ‘a’ flagging at a later point.

This position is in line with the recent PBAC recommendation to list the biosimilar insulin glargine Basaglar, where the committee also said that it would consider marking the biosimilar as equivalent, i.e. ‘a’ flagging [1].

This marks a change in position of the PBAC, which has previously not considered ‘a’ flagging biosimilars, stating that ‘The current practice of ‘a’ flagging in the Schedule of Pharmaceutical Benefits, denoting that brand substitution may be undertaken by pharmacists at the point of dispensing, will not be applied to SBMPs [similar biological medicinal products, i.e. biosimilars] at this time unless a Therapeutic Goods Administration issued statement supportive of ‘a’ flagging is available’. And in fact it has even previously rejected ‘a’ flagging in the case of the filgrastim biosimilar, Nivestim [1].

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1.   GaBI Online - Generics and Biosimilars Initiative. Australian approval for biosimilar insulin []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from:

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Source: PBS

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Posted 19/06/2015 by Dr Stephane Shekar, MD
biologic substitution by biosimilar

Biosimlars are an excellent way of providing healthcare to a wider patient base and therefore as such are a good way to save money while saving lives and long-term dividents are certain. Having said that, biosimlar manufacturers must also play their part in the disease awarenss campaign and not try to catch marketshare on the cheap.
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