# Biosimilarity and Interchangeability:  Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/biosimilarity-and-interchangeability-additional-draft-qas-on-biosimilar-development-and-the-bpci-act-revision-1-draft-guidance-for-industry/b8ab7745-3ad5-4de1-8e9c-9262c73cdacd

> FDA guidance document: Biosimilarity and Interchangeability:  Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for Industry. Issue date: September 18, 2023. Get complete insights and analysis.

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## Details

- Title: Biosimilarity and Interchangeability:  Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-09-18
- Last Changed: 2023-11-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0611">FDA-2011-D-0611</a>

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- [New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)”](https://www.globalkeysolutions.net/guidances/guidance-document/new-and-revised-draft-qas-on-biosimilar-development-and-the-bpci-act-revision-3-draft-new-and-revised-draft-qas-on-biosimilar-development-and-the-bpci-act-revision-3/fa17132a-ca0a-4f0c-8b68-5b45a40f4059)