Patent expiry and biosimilars: difference between revisions
Diff·revision 10 → 11·17:01, 20 Apr 2025
Difference between revision 10 and revision 11 of Patent expiry and biosimilars. 8 lines changed; the page grew by 369 bytes.
| Revision 10 — 11:28, 30 Mar 2025 BiliaryBea (talk) add the effective date to the regulatory table 3,211 bytes +38 | Revision 11 — 17:01, 20 Apr 2025 BiosimilarBoaz (talk) attribute the compounding statement to the pharmacy board that issued it 3,580 bytes +369 | ||
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| 25 | 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}} | 25 | 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}} |
| 26 | 26 | ||
| + | 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 | ||
| 27 | == References == | 29 | == References == |
| 28 | {{reflist}} | 30 | {{reflist}} |
| ⋮ | ⋮ | ||
| 30 | <ref name="fda_peptide">United States Food and Drug Administration, ''ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin'' (guidance for industry).</ref> | 32 | <ref name="fda_peptide">United States Food and Drug Administration, ''ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin'' (guidance for industry).</ref> |
| 31 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 33 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 34 | ||
| + | 35 | == See also == | |
| + | 36 | * [[Cost per milligram]] | |
| + | 37 | * [[Regulatory status by jurisdiction]] | |
| + | 38 | * [[Active pharmaceutical ingredient]] | |
| + | 39 | * [[Analytical method validation]] | |
| 32 | 40 | ||
| 33 | {{DEFAULTSORT:Patent expiry and biosimilars}} | 41 | {{DEFAULTSORT:Patent expiry and biosimilars}} |