Table 1.

Comparison of the registration application for generic products, biosimilar products, and new (original) products

	Classical equivalent product	Biosimilar product	New product (Complete dossier)
Quality	Comparison of the “Dossier information of Complete and Independent Product”	“Dossier information of Complete and Independent Product” Extensive comparison with the reference product	Dossier information of Complete and independent product
Preclinical	-	Abridged program, subchronic toxicity study affiliated with the complexity of the molecule (4 weeks). Local tolerance, PK/PD (pharmacokinetic/pharmacodynamic) study	Preclinical complete study
Clinical	Bioequivalence study	Phase I: PK/PD (pharmacokinetic/pharmacodynamic) study Phase II study is not required. Where necessary, phase III study for each indication Risk management plan	Phase I Phase II Phase III studies in all indications Risk management plan