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.