Patent expiry and biosimilars (revision 2)
Old revision·01:58, 17 Dec 2024·CoI_Corin
| Patent expiry and biosimilars | |
|---|---|
| Generic | Demonstrated identical active substance |
| Biosimilar | Highly similar, with comparability exercise |
| Peptides | May follow either route, jurisdiction-dependent |
| Topic infobox · conventions | |
Patent protection and regulatory exclusivity together determine when a competitor may market a copy of an approved product. When both lapse, entry becomes possible by one of two routes: as a generic, demonstrating that the active substance is the same, or as a biosimilar, demonstrating high similarity through a comparability exercise.[1]
Synthetic peptides sit awkwardly between the categories. They are made by chemical synthesis like small molecules, but are large enough that impurity profiles and higher-order structure may differ between manufacturers in ways a small-molecule generic pathway was not designed to address.[2]
The two pathways
[edit]A generic application demonstrates that the active substance is the same as the reference product and that the finished product is bioequivalent. No clinical efficacy trial is generally required.[1]
A biosimilar application demonstrates high similarity through analytical comparability, supported by pharmacokinetic and, where necessary, clinical data. The bar is similarity rather than identity, because biological manufacture cannot produce identity.[1]