Table 2.

Regulatory definitions of biosimilars

Regulatory body	Definition
EMA39	A biological medicinal product that contains a version of the active substance of an already authorized product (reference medicinal product) in the EEA
FDA38	A biological product that is highly similar to a US-licensed reference product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product

Abbreviations: EEA, European Economic Area; EMA, European Medicines Agency; FDA, US Food and Drug Administration.