# Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product/b98b0335-f4b7-4a14-88b1-7ea4d02c7e37

> FDA guidance document: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Issue date: April 28, 2015. Get complete insights and analysis.

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## Details

- Title: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
- 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: 2015-04-28
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0605">FDA-2011-D-0605</a>

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