# Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/clinical-immunogenicity-considerations-for-biosimilar-and-interchangeable-insulin-products/a298f68f-edb6-4662-b8d8-18120d2ae9f0

> FDA guidance document: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products. Issue date: November 25, 2019. Get complete insights and analysis.

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## Details

- Title: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-11-25
- Comment Close Date: 2020-01-28
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/ FDA-2019-D-5255"> FDA-2019-D-5255</a>

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