Table 1.

Key Biosimilars Adoption Factors, by Stakeholder

Stakeholder	Key adoption factors
Payers	General perception on biosimilars—acceptability of clinical data package used for regulatory approval Pricing power—ability to induce price competition, for example, through tendering processes and need for pricing negotiations at the national, regional, and local level In the United States, regulation of therapeutic interchange and automatic substitution is controlled by state pharmacy boards and state laws, which may vary between states
Physicians	Noninferior versus equivalent versus better clinical outcomes to the originator drug; concerns highlighted include extrapolation of clinical data into other indications or to patients with different characteristics, variability of efficacy (batch-to-batch), immunogenicity, other safety concerns Experience in switching patients from reference drug to biosimilars Uncertainty in biosimilar performance resulting from shifts in standards of care that were used to evaluate the utility of the reference product Absence of tools to assess clinical value in individual patients after biosimilar commercialization
Patients	Concern over manufacturers' know-how and manufacturer capabilities, especially for brand-loyal patients Uncertainty regarding longer-term efficacy and safety outcomes Inability to distinguish and interpret evolving concepts, such as interchangeable biologic drugs