Patent expiry and biosimilars: difference between revisions
Diff·revision 15 → 16·12:11, 25 Jul 2025
Difference between revision 15 and revision 16 of Patent expiry and biosimilars. 6 lines changed; the page grew by 603 bytes.
| Revision 15 — 16:41, 8 Jul 2025 RedirectRini (talk) fix the anchor on an internal link 3,580 bytes ±0 | Revision 16 — 12:11, 25 Jul 2025 ITT_Imelda (talk) serial comma per PP:MOS 4,183 bytes +603 | ||
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| 27 | The consequence is that a peptide generic is a more analytically demanding application than a small-molecule generic, and the analytical package rather than the clinical one carries the argument.{{r|fda_peptide}} | 27 | The consequence is that a peptide generic is a more analytically demanding application than a small-molecule generic, and the analytical package rather than the clinical one carries the argument.{{r|fda_peptide}} |
| 28 | 28 | ||
| + | 29 | == Consequences for supply == | |
| + | 30 | Patent expiry changes the commercial landscape rather than the chemistry. A molecule whose protection has lapsed can be made and sold lawfully by anyone able to meet the regulatory requirements, and prices fall accordingly. See [[Cost per milligram]].{{r|ema_biosimilar}} | |
| + | 31 | ||
| + | 32 | It does not change the status of research-chemical supply, which is a separate category question: material sold as a reagent is not a medicine regardless of whether the reference product is still protected. See [[Regulatory status by jurisdiction]].{{r|usp1503}} | |
| + | 33 | ||
| 29 | == References == | 34 | == References == |
| 30 | {{reflist}} | 35 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | * [[Active pharmaceutical ingredient]] | 43 | * [[Active pharmaceutical ingredient]] |
| 39 | * [[Analytical method validation]] | 44 | * [[Analytical method validation]] |
| + | 45 | * [[Solid-phase peptide synthesis]] | |
| 40 | 46 | ||
| 41 | {{DEFAULTSORT:Patent expiry and biosimilars}} | 47 | {{DEFAULTSORT:Patent expiry and biosimilars}} |