# Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/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. --- ## 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: FDA-2019-D-2102 ## Related Documents - [Classification Categories for Certain Supplements Under BsUFA III](https://www.globalkeysolutions.net/guidances/guidance-document/classification-categories-for-certain-supplements-under-bsufa-iii/66d51a68-e6a8-4e86-8097-7ddf219d36b9) - [Classification Categories for Certain Supplements Under BsUFA III](https://www.globalkeysolutions.net/guidances/guidance-document/classification-categories-for-certain-supplements-under-bsufa-iii/f09c6e0e-9036-4b71-a1b0-4304825ad58b) - [Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/development-of-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality-related-considerations-guidance-for-industry/3949c599-c5d4-49ab-bdd6-82c279429c92)