Table 2.

Comparison of data requirement for generics versus similar biological medicinal products. BE: bioequivalence; PMS: postmarketing study.

Classic generics		Biosimilars
Manufacturing	Chemical synthesis	Genetically modified cell lines
	Simple microbial fermentation	Complex fermentation process
	Standard analytics	Complex purification process
		Formulation
		Complex analytical characterization
Preclinic	Generally none	In vitro/in vivo bioassay
		Toxicity studies
		Local tolerance studies
		PK/PD studies
Clinic	Generally BE study	Phase I PK/PD
		Phase III studies
		Phase IIIb studies
		Phase IV studies (PMS)