Table 1.

Comparison of biologics and biosimilars

	Biologics	Biosimilars
Manufacturing	Heterogeneous product	Heterogeneous product
Immunogenicity	Potential risk	Potential risk
Regulation	BLA	aBLA
Indications	Only for those approved by the US Food and Drug Administration	All indications of the original biologics
Potential for patent licensing	Yes	No
Potential for exclusivity period	Yes, 12 years	No
Potential for interchangeability	No	Yes

Note: Data from Blackstone and Fuhr⁵ and Camacho et al.⁹

Abbreviations: BLA, biologics license application; aBLA, abbreviated biologics license application.