# Development of Therapeutic Protein Biosimilars:  Comparative Analytical Assessment and Other Quality-Related Considerations   Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/development-of-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality-related-considerations-guidance-for-industry/07142307-dadf-4c95-927c-469f261c1c58

> FDA guidance document: Development of Therapeutic Protein Biosimilars:  Comparative Analytical Assessment and Other Quality-Related Considerations   Guidance for Industry. Issue date: September 09, 2025. Get complete insights and analysis.

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## Details

- Title: Development of Therapeutic Protein Biosimilars:  Comparative Analytical Assessment and Other Quality-Related Considerations   Guidance for Industry
- 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: 2025-09-09
- Last Changed: 2025-09-08
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-2102">FDA-2019-D-2102</a>

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