Table 4.

Regulatory characteristics of biosimilars and generics.

	Biosimilars	Generics
Originated from	Biologic medicines	Conventional medicines
Development paradigm	Highly similar and not identical to the originator (comparative studies)	Bioequivalent and identical to the originator (bioequivalence studies)
Approval procedure	Usually approved from central regulatory authorities EMA or FDA	Usually approved from national regulatory authorities of EU or FDA
Immunogenicity	Yes	No
Nomenclature	Trade names or the use of distinguishable names with distinct suffixes	INN names
Interchangeability	Not yet assessed, established or approved	Yes
Substitution	Not yet assessed and established or approved	Yes
ADR	Report the INN name manufacturer and batch number	Report the INN name
Risk management plan	Yes	No
Price discount	20–30% discount over the originator	80–90% discount over the originator
Timeline development	8–10 years	3–5 years
Development cost	$100–$200 M	$1–$5 M