Table 3

Definitions of therapeutic products

ProductAlternative namesDefinition
GenericExact copy of a small-molecule drug, synthesised via chemical means, with structural and therapeutic identity to the reference product
BiosimilarFollow-on biologic (USA); subsequent entry biologic (Canada); similar biotherapeutic product (WHO)A biological product that is highly similar to a reference product in terms of quality, safety and efficacy and/or safety, purity and potency demonstrated by rigorous comparability exercises
Second-generation biologicalBiobetterA structurally/functionally altered biological product resulting in improved or different biological activity from the reference
Me-too biologicalNon-innovator biologicalA biological product developed with the same target antigen but without demonstrated comparability to the reference product