# Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/quality-considerations-in-demonstrating-biosimilarity-of-a-therapeutic-protein-product-to-a-reference-product-guidance-for-industry/f1b25c36-0d87-42be-b734-ad29acc267ea

> FDA guidance document: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry. Issue date: April 30, 2015. Get complete insights and analysis.

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## Details

- Title: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2015-04-30
- Last Changed: 2020-02-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0602">FDA-2011-D-0602</a>

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