Definitions of therapeutic products
| Product | Alternative names | Definition |
|---|---|---|
| Generic | – | Exact copy of a small-molecule drug, synthesised via chemical means, with structural and therapeutic identity to the reference product |
| Biosimilar | Follow-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 biological | Biobetter | A structurally/functionally altered biological product resulting in improved or different biological activity from the reference |
| Me-too biological | Non-innovator biological | A biological product developed with the same target antigen but without demonstrated comparability to the reference product |