Biosimilars on the PBS
Page last updated: 30 September 2016
The PBS Access and Sustainability Package, including the Sixth Community Pharmacy Agreement (6CPA), includes measures to support the use and awareness of biosimilar medicines and ensure appropriate policies can be applied to provide market access and increase consumer choice and access and achieve the savings that can be gained from the use of these products.
The Government is investing $20 million over 2015-18 for activities designed to improve awareness and confidence in biosimilar medicines, for both health professionals and consumers.
Fact Sheets on biosimilar medicines
You can access a copy of the Fact Sheets on biosimilar medicines here:
- Biosimilar Medicines – Factsheet for Patients and Consumers
- Biosimilar Medicines – Factsheet for Healthcare Professionals
Biosimilar infliximab on the PBS
Since 1 December 2015, a biosimilar infliximab (Inflectra®) has been listed on the PBS for the same indications as Remicade®. Information has been provided to health professionals and patient groups, which you can access here:
- Fact sheet – Biosimilar infliximab on the PBS
- Letter to prescribers – Biosimilar infliximab on the PBS
- Letter to pharmacists – Biosimilar infliximab on the PBS
Biosimilar Awareness Initiative Project Management Plan
The purpose of the Project Management Plan is to provide a framework for the project and to guide the progress of the Initiative over the three year term. As part of the project governance, the Department established a Steering Committee and a Stakeholder Reference Group. Both the Steering Committee and the Reference Group have been consulted regarding the Project Management Plan.
The Plan will be used to inform the longer term development and implementation of the awareness project.
You can access a copy of the Project Management Plan here:
Biosimilar Literature Review
To form the evidence base for the Initiative, the Department procured the University of South Australia (UniSA) to conduct a comprehensive literature search and review.
The Review Authors, Michael Ward, PhD BPharm (Hons), Stephanie Reuter Lange, PhD BSc(Hons) & Kirsten Staff, PhD, MPharm, PGCertEd, conducted a search of all international and Australian clinical, academic and policy journals and other media articles reported in English language between 1 June 2004 and 28 April 2016.
The findings of the literature review are used to ensure that the core messages of the Initiative remain relevant in a changing environment.
The issues-based themes below have been used to categorise the literature within the report:
- Determining Access and Subsidisation: Regulatory, Government and Healthcare Provider Biosimilar Medicine Policies to Subsidisation, Switching and Substitution;
- Biosimilar Medicine Uptake: Current Practice of Prescribers, Pharmacists and Patients;
- Adverse Events and Health Outcomes of Biosimilar Medicines (Pharmacovigilance): Impact of Substitution, Switching and Extrapolation of Indication; and
- Evaluating and Improving Stakeholder Biosimilar Awareness, Confidence, Attitudes and Acceptance of Biosimilar Medicine.
You can access a copy of the Literature Review here:
Ongoing literature reviews will be conducted to support the evidence bas required for the communication activities of the Initiative.
Biosimilar Awareness Initiative Reference Group
The Biosimilar Awareness Initiative Reference Group (the Reference Group) was established to give guidance on the activities of the Biosimilar Awareness Initiative and ensure key messages are clearly articulated and appropriately targeted.
Members of the Reference Group consists of stakeholders from the pharmaceutical industry, consumers, pharmacists and relevant medical authorities.
The Reference Group had its inaugural meeting in Canberra on 07 April 2016
The second meeting of the Reference Group was held in Canberra on 12 May 2016
- Reference Group Communiqué 2 (PDF 25KB) - (Word 35KB)
- Presentation 1 – ORC Market Research (PDF 1.5MB) - (PowerPoint 17MB)
- Presentation 2 – PBS Data Presentation (PDF 356KB) - (PowerPoint 237KB)
The third meeting of the Reference Group was held in Canberra on 18 August 2016