Patent expiry and biosimilars: difference between revisions
Diff·revision 7 → 8·03:34, 25 Feb 2025
Difference between revision 7 and revision 8 of Patent expiry and biosimilars. 5 lines changed; the page grew by 595 bytes.
| Revision 7 — 10:34, 12 Feb 2025 BaselineBex (talk) name the regulator rather than writing "the authorities" 2,578 bytes ±0 | Revision 8 — 03:34, 25 Feb 2025 BUD_Bertram (talk) add the date the shortage listing ended 3,173 bytes +595 | ||
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| 19 | For a synthetic peptide, identity of the active substance is in principle demonstrable, which points to the generic pathway. What complicates it is that impurities differ between synthetic routes, and an impurity absent from the reference product raises questions a bioequivalence study does not answer.{{r|fda_peptide}} | 19 | For a synthetic peptide, identity of the active substance is in principle demonstrable, which points to the generic pathway. What complicates it is that impurities differ between synthetic routes, and an impurity absent from the reference product raises questions a bioequivalence study does not answer.{{r|fda_peptide}} |
| 20 | 20 | ||
| + | 21 | == Why impurities decide it == | |
| + | 22 | Guidance for synthetic peptide generics focuses on the impurity profile: a proposed generic must show that any impurity not present in the reference product, or present at higher level, does not raise a safety or immunogenicity concern.{{r|fda_peptide}} | |
| + | 23 | ||
| + | 24 | This is the same argument that runs through the analytical articles on this wiki. Peptide impurities are structurally close to the peptide, are route-dependent, and are what an [[Analytical method validation|adequately specific method]] exists to resolve. See [[Solid-phase peptide synthesis]].{{r|usp1503}} | |
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| 21 | == References == | 26 | == References == |
| 22 | {{reflist}} | 27 | {{reflist}} |