Eight guiding principles for biosimilars

Tuesday, 23 Jun 2015

The Council of Australian Therapeutic Advisory Groups (CATAG) has developed eight guiding principles to assist Australian hospitals provide good governance and decision-making in relation to their use of biologic therapies.

1. The governance of biologics/ biosimilars within the hospital system should be no different to that of any other medicine.

2. The selection of a biologic/ biosimilar as first-line therapy in treatment-naïve patients should be subject to evidence of safety, efficacy and cost-effectiveness.

3. Biologics/biosimilars should be prescribed by both the active ingredient name and the brand name.

4. A biologic and its biosimilars are not interchangeable at dispensing and should only be substituted with the prescriber’s knowledge and consent.

5. Patients should be fully informed when receiving treatment with a biologic/biosimilar.

6. Switching between a biologic and its biosimilars should be in accordance with a drug and therapeutics committee–approved treatment protocol that includes a monitoring plan.

7. The selection of a biologic/ biosimilar as second-line therapy should be in accordance with a treatment pathway approved by the drug and therapeutics committee.

8. There should be a patient-centred pharmacovigilance framework within each hospital or health service to monitor and report outcomes and any adverse effects associated with biologic/ biosimilar therapy.

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