# Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference  Product - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/clinical-pharmacology-data-to-support-a-demonstration-of-biosimilarity-to-a-reference-product/d14d1e42-3cce-41e9-863f-79be3022abbb

> FDA guidance document: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference  Product. Issue date: December 29, 2016. Get complete insights and analysis.

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## Details

- Title: Clinical Pharmacology Data to Support a Demonstration of 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: 2016-12-29
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0234">FDA-2014-D-0234</a>

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