Table 1.

Names and Definitions of Biologic Copies According to Different Regulatory Agencies

Agency	Naming	Definition
FDA (Food and Drug Administration), USA	Follow‐on Biologic or Biosimilar	“A biological product that is highly similar to a U.S.‐licensed reference biological 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 the safety, purity, and potency of the product”.16
EMA (European Medicines Agency)	Biosimilar	“A biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the EEA. Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established”.4
WHO (World Health Organization)	Similar Biotherapeutic Product	“A biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”.17
PMDA (Pharmaceutical and Medical Devices Agency), Japan	Follow‐on Biologic or Biosimilar	“A biotechnological drug product developed by a different company to be comparable to an approved biotechnology‐derived product (hereinafter “reference product”) of an innovator”.18
Health Canada	Subsequent Entry Biologic	“A biologic product that is similar to and would enter the market subsequent to an approved innovator biologic product”.19
ANVISA (Agência de Vigilância Sanitária), Brazil	Biologic Product	A biologic medicine with known biologic activity that contains no new molecules, already licensed in Brazil and that has gone through all the production steps (including formulation, vialing, freeze drying, labeling, packaging, storage, quality control and biologic product lot release).20