Patent expiry and biosimilars (revision 1)
Old revision·09:00, 12 Dec 2024·GMP_Gita
This is an old revision of this page, as it stood at 09:00, 12 Dec 2024, saved by GMP_Gita with the summary new article: drug regulation, expansion welcome. It may differ substantially from the current revision, and any error it contains may since have been corrected.
| 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]
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