Table 1.

Consensus on components of a sustainable biosimilar market.

I.  A sustainable biosimilar market must deliver tangible and transparent benefits to the health care system
Biosimilars have the potential to reduce the cost of treatment; this, in turn, strengthens the sustainability of health care expenditure
Biosimilar-related savings must be tangible and transparent and should be reinvested efficiently; this may include addressing deficits, and funding innovative therapies, health care or other public services. Biosimilars have the potential to expand access
Providers (physicians and pharmacists) incur real costs when transitioning to a new biosimilar; transition should only occur if savings substantially exceed these transition costs and a portion of the savings are used to meet these costs
II.  A sustainable biosimilar market must address the needs of all stakeholders
Transitioning between biosimilars causes disruption to patient care and health care services. Unnecessary disruptions (i.e., frequent transitions and/or transitions that do not deliver tangible savings) should be minimized
Disruption caused by biosimilar transition may be unavoidable in some therapeutic areas (e.g., acute vs. chronic conditions); however, switch is not advisable if treatment duration is short
Disruption and transition costs occur in both hospital and out-of-hospital (including retail and home care) settings; these differences may need to be considered
III.  A sustainable biosimilar market requires collaboration between stakeholders
Policies and practices must encourage trust in biosimilar use among patients through effective communication between stakeholders
Language and messaging should be consistent among stakeholders and coordinated nationally
Clear guidance from regulators and clinical organisations at European and national levels is required to motivate multiple switches (i.e., following the initial transition from original biological to biosimilar)
This guidance may benefit from real-world studies (e.g., registry studies)–although not all stakeholders agree that this would be sufficient evidence
Research would need to be led by providers (pharmacists and physicians), as there are limited incentives for manufacturers to invest in this research

Note: icons shown on the right represent level of agreement between the stakeholders. The ‘consensus’ icon indicates that all stakeholders (physicians, payers, policy advisors, manufacturers, pharmacists, and patients) agreed on that point. Benefits, such as expanded access, have also been noted in the literature [9].