Guidance on information and submission requirements for biosimilar biologic drugs.: H164-427/2026E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.962824&sl=0
| Department/Agency |
|
|---|---|
| Title | Guidance on information and submission requirements for biosimilar biologic drugs. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
| Note(s) |
|
| Publishing information |
|
| Description | 1 online resource (i, 30 pages) |
| ISBN | 9780660999661 |
| Catalogue number |
|
| Departmental catalogue number | 260112 |
| Subject terms |
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