Table 2.

Consensus on drivers and risks to biosimilar market sustainability (competition and incentives).

I.  Competition is a more effective mechanism to achieve a long-term predictable price level than regulation
Increased competition leads to more rapid price reduction and, if procurement policies contribute to business continuity, a sustained lower price level
There is a need to develop better prospective indicators to warn about potential risk of de facto monopoly
Existing indicators, such as the number of manufacturers and manufacturing sites for biosimilars, are imperfect and may only indicate a problem that is too late to reverse Additional indicators that could be explored include procurement design (e.g., contract length), geographic division (national vs. regional) and factors other than cost
New entrants may bring minor improvements (e.g., administration devices), although competition has been primarily price-focused and has led to a reduction in “value-add” (e.g., patient support programs)
Price-setting regulation, if needed to prevent predatory behaviour, should not aim primarily at the lowest possible prices but at long-term viability of a vibrant and competitive marketplace
II.  There needs to be incentives for investment in future biosimilars
Continued investment in biosimilar development and market entry is important to generate competition for biological therapies for which no biosimilar is currently available and, to a lesser extent, therapies with biosimilars already available
Price expectations of policy and budget holders must reflect market opportunity, e.g., biosimilars of orphan therapies may require lower price discount levels
A stable, predictable price level enables manufacturers to make the long-term decisions that are required to invest in biosimilar development
III.  Governments and pricing bodies need to drive incentives
These bodies need to supply incentives that enable enough suppliers to survive free market onslaught; this may assure the continuity of long-term competition and sustainable discounts from originator biological therapy price levels
This could be achieved by varying tender available to manufacturers

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.