# New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/new-and-revised-draft-qas-on-biosimilar-development-and-the-bpci-act-revision-4-draft-guidance-for-industry/887fce8a-3c4a-41cd-9f2c-8e1e159e3547

> FDA guidance document: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry. Issue date: March 09, 2026. Get complete insights and analysis.

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## Details

- Title: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry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: 2026-03-09
- Last Changed: 2026-03-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0611">FDA-2011-D-0611</a>

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