AMWG / GMWG Biosimilar Policy Subgroup
Page last updated: 5 June 2019
The Combined Biosimilar Policy Subgroup (Combined Subgroup) will consider ways to support the formation of a functioning and competitive biosimilars market in Australia.
The Sub-group will monitor and report on the impact of current biosimilar policy within the Australian market in line with the objectives of the National Medicines Policy.
The Subgroup may identify current and future barriers for market entry and uptake for biosimilar medicines, and discuss possible approaches to address and overcome these barriers.
The Combined Sub-group will discuss activities underway to address public confidence and knowledge around biosimilar medicines.
The Sub-group will focus on concerns raised at an industry level, rather than company specific concerns. The Combined Subgroup will feed into both the Generic Medicines Working Group and the Access to Medicines Working Group.
Activities may include
- Monitor the PBS listed brands of biological medicines as a measure of policy success.
- Identify current and future barriers for market entry for biosimilar medicines, and discuss possible approaches to address and overcome these barriers.
- Monitor international biosimilar policy developments, putting forward options for Australian policy reform as appropriate.
- Provide comment from an industry perspective on the impact of regulatory and reimbursement policy for biosimilars (such as naming, adoption of European guidelines, PBAC guidelines) on the formation of the Australian biosimilars market.
- Monitor and report on biosimilar access in term of each of the objectives of the National Medicines Policy.