Patent expiry and biosimilars: difference between revisions
Diff·revision 18 → 19·01:50, 4 Oct 2025
Difference between revision 18 and revision 19 of Patent expiry and biosimilars. 3 lines changed; the page grew by 370 bytes.
| Revision 18 — 10:49, 8 Sep 2025 Chromatokid (talk) state that the position differs between jurisdictions and give two examples 4,183 bytes ±0 | Revision 19 — 01:50, 4 Oct 2025 ArchiveBot (talk) bot: expand DOI to full citation 4,553 bytes +370 | ||
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| 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}} | 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 | 33 | ||
| + | 34 | Nor does it change what a [[Certificate of analysis|certificate]] establishes. The impurity argument above applies with more force outside licensed supply, not less, because there is no comparability exercise at all.{{r|reports}} | |
| + | 35 | ||
| 34 | == References == | 36 | == References == |
| 35 | {{reflist}} | 37 | {{reflist}} |
| ⋮ | ⋮ | ||
| 37 | <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> | 39 | <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> |
| 38 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 40 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 41 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 39 | 42 | ||
| 40 | == See also == | 43 | == See also == |