# Labeling for Biosimilar and Interchangeable Biosimilar Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-biosimilar-and-interchangeable-biosimilar-products/54a5f712-03f5-4993-b0d7-6a1c2f261eff

> FDA guidance document: Labeling for Biosimilar and Interchangeable Biosimilar Products. Issue date: September 18, 2023. Get complete insights and analysis.

---

## Details

- Title: Labeling for Biosimilar and Interchangeable Biosimilar Products
- 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: 2023-09-18
- Comment Close Date: 2023-11-17
- Last Changed: 2023-09-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-0643">FDA-2016-D-0643</a>

## Related Documents

- [Master Protocols for Drug and Biological Product Development](https://www.globalkeysolutions.net/guidances/guidance-document/master-protocols-for-drug-and-biological-product-development/401e65ec-7388-4389-a95a-dc8860a1ce51)
- [Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/gluten-in-drug-products-and-associated-labeling-recommendations-draft-guidance-for-industry/7c089d7c-0cae-4796-899d-09c5a25a376f)
- [Nonproprietary Naming of Biological Products: Update Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/nonproprietary-naming-of-biological-products-update-guidance-for-industry/8adaef5a-6903-4e65-ac57-121d51429730)
