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The Pharmacy Guild of Australia’s position statement on substitution of biosimilar medicines

Medicine, Nursing, Pharmacy

The Pharmacy Guild of Australia has released a position statement supporting the Australian Government’s policies that encourage the use of biosimilar medicines to contain the cost of the Pharmaceutical Benefits Scheme (PBS). A biosimilar medicine is a version of an already registered biological medicine that has a demonstrable similarity in physicochemical, biological and immunological characteristics, efficacy and safety.

Following are key points on the Guild’s position:

  • The acknowledgement that substitution is cost-saving to both government and patients as well as facilitating market competition.
  • Noting that the Therapeutic Goods Administration (TGA) is responsible for registering and evaluating medicines.
  • Acknowledging that the sponsors have submitted evidence to the TGA where the Pharmaceutical Benefits Advisory Committee (PBAC) has ‘a’ flagged a PBS item.
  • Recognising the additional assessment processes required by the TGA for biosimilar medicines such as the physicochemical characteristics and efficacy and safety outcomes.
  • The belief that the patients should be informed of the availability of an alternative medicine when a biological medicine has been ‘a’ flagged.
  • Encouraging pharmacies to have protocols for their staff to avoid patient confusion in relation to biosimilars by reinforcing the name of the active ingredient when prescribing, dispensing, labelling and administering medicines to patients.

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