Table 2.

Differences in regulatory requirements for originator compounds, generics, and biosimilars

	New chemical entity or originator biologic	Generic	Biosimilar
Quality	Full process and product characterization	Full process and product characterization Comparison with reference drug	Full process and product characterization Comparison with reference biologic
Preclinical	Full preclinical program	N/A	Abbreviated program based on complexity and residual uncertainty from quality
Clinical	Phase I	Bioequivalence only	PK equivalence PD equivalence (dose response) if marker available
	Phase II	N/A	N/A
	Phase III in all indications	N/A	Phase III in at least one representative indicationa
	Risk management planb	Yes	Yes
	Pharmacovigilance	Yes	Yes

N/A not applicable, PK pharmacokinetics, PD pharmacodynamics

^aIf the mechanism of action is the same across extrapolated indications

^bRequirement for the European Union only