TABLE 4.

Elements that should underpin sustainable biosimilar policy development over time.

Sustainable biosimilar policies should:
INITIALLY AND AT A MINIMUM
1	Ensure safe and high-quality medicines	Policies should ensure high quality medicines with robust and transparent evaluations, and monitoring systems to give confidence to patients and healthcare professionals
2	Facilitate cost savings for healthcare providers	Policies should facilitate cost savings for healthcare systems to ensure long-term budget sustainability
3	Ensure healthy levels of supply	Policies should minimise risks of supply shortage and ensure there is sufficient demand for biosimilars to avoid wastage or incentives to sell at unsustainable prices
4	Maintain incentives for continued biologic research & innovation	Policies should ensure that sufficient incentives for manufacturers remain in place to ensure that there is continued research to launch new biologic products
AS BIOSIMILAR POLICY MATURES
5	Mitigate against biosimilar misconceptions	Policies should seek to address common concerns surrounding biosimilars to optimise uptake and ensure informed decision-making across all stakeholders
6	Facilitate efficient & streamlined patient access	Policies should encourage streamlined access procedures without compromising safety to ensure eligible patients have unrestricted access to life-saving medicines
7	Encourage multi-stakeholder decision-making	Policies should ensure that all key stakeholders (payers, physicians, pharmacists and patients) play a role within decision-making to optimise multi-stakeholder benefits
FINALLY TO ENSURE LONG-TERM SUSTAINABILITY
8	Facilitate sustainable levels of biosimilar competition	Policies should ensure that market competition is incentivised to ensure long-term predictable price levels, while delivering savings that may be reinvested
9	Increase prescribing options for patients & healthcare professionals	Policies should encourage availability of multiple prescribing options to maintain flexibility in treatment regimens to address individualised patient needs
10	Maintain predictable market functioning	Policies should ensure that market volatility is kept to a minimum and that policies are transparent to maintain attractivity of thes market
BENEFITS FOR:= All stakeholders= Patient= Healthcare Professional= Payers / Budget Holder= Biosimilar & Originator Manufacturers