Patent expiry and biosimilars: difference between revisions
Diff·revision 4 → 5·15:35, 14 Jan 2025
Difference between revision 4 and revision 5 of Patent expiry and biosimilars. 6 lines changed; the page grew by 736 bytes.
| Revision 4 — 14:27, 5 Jan 2025 ShortageShona (talk) add short description 1,842 bytes ±0 | Revision 5 — 15:35, 14 Jan 2025 TrialsTabitha (talk) add the citation for the regulatory action 2,578 bytes +736 | ||
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| 10 | 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.{{r|usp1503}} | 10 | 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.{{r|usp1503}} |
| 11 | 11 | ||
| + | 12 | Which pathway applies differs by jurisdiction and by molecule, and guidance specific to synthetic peptide generics has been issued to address exactly this.{{r|fda_peptide}} | |
| + | 13 | ||
| 12 | == The two pathways == | 14 | == The two pathways == |
| 13 | 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.{{r|ema_biosimilar}} | 15 | 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.{{r|ema_biosimilar}} |
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| 15 | 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.{{r|ema_biosimilar}} | 17 | 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.{{r|ema_biosimilar}} |
| 16 | 18 | ||
| + | 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}} | |
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| 17 | == References == | 21 | == References == |
| 18 | {{reflist}} | 22 | {{reflist}} |
| 19 | <ref name="ema_biosimilar">European Medicines Agency, ''Guideline on Similar Biological Medicinal Products'' (CHMP/437/04 Rev 1).</ref> | 23 | <ref name="ema_biosimilar">European Medicines Agency, ''Guideline on Similar Biological Medicinal Products'' (CHMP/437/04 Rev 1).</ref> |
| + | 24 | <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> | |
| 20 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 25 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 21 | 26 | ||
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| 23 | [[Category:Intellectual property]] | 28 | [[Category:Intellectual property]] |
| 24 | [[Category:Regulation and law]] | 29 | [[Category:Regulation and law]] |
| + | 30 | [[Category:Drug regulation]] | |
| 25 | 31 |