Guidance Document: Information and Submission...
Dataset description:
This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and...
Source: Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs
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Additional Information
| Field | Value |
|---|---|
| Data last updated | October 20, 2025 |
| Metadata last updated | October 20, 2025 |
| Created | October 20, 2025 |
| Format | HTML |
| License | Open Government Licence - Canada |
| Has views | False |
| Id | e332ec05-9ff9-4f6c-9e1f-635e199dd6f3 |
| Package id | 063449eb-192d-45d4-87fa-a347d11e49b9 |
| Position | 1 |
| State | active |