| 000 | 00000cam 2200000zi 4500 |
| 001 | 9.962824 |
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| 003 | CaOODSP |
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| 005 | 20260525120847 |
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| 006 | m o d f |
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| 007 | cr cn |||||||| |
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| 008 | 260515t20262026onc o f000 0 eng d |
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| 020 | |a9780660999661 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-427/2026E-PDF |
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| 245 | 00|aGuidance on information and submission requirements for biosimilar biologic drugs. |
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| 264 | 1|aOttawa : |bHealth Canada = Santé Canada, |c2026. |
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| 264 | 4|c©2026 |
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| 300 | |a1 online resource (i, 30 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued also in French under title: Lignes directrices sur les exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaires. |
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| 520 | |a"This guidance document applies to all biologic drug submissions for which the sponsor seeks authorization for sale based on a demonstrated high degree of similarity to a previously authorized biologic drug. These submissions rely on prior information regarding that biologic drug to support, in part, a reduced clinical package as part of the submission"--page 3. |
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| 650 | 0|aBiologicals|xGovernment policy|zCanada. |
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| 650 | 0|aDrug approval|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaires.|w(CaOODSP)9.962825 |
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| 856 | 40|qPDF|s742 KB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-427-2026-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs.html |
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| 986 | |a260112 |
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