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Purple book dupilumab biosimilar?

Short answer: As of the last update I have, there are no FDA-approved dupilumab biosimilars listed in the FDA Purple Book. Dupixent (dupilumab) is the reference product, and no biosimilar or interchangeable version has been approved in the US yet.

How to check yourself:
- Visit the FDA Purple Book page: https://www.fda.gov/drugs/biosimilars/purple-book-list
- Search for “dupilumab” or “Dupixent” (you can also search by the BLA number if you have it).
- If any biosimilars or interchangeable versions exist, they will appear with their sponsor, product name, and interchangeability status.

Notes:
- The Purple Book is US-focused. A non-US biosimilar may exist in other countries, but that wouldn’t appear in the Purple Book.
- Interchangeable status is required for automatic pharmacy substitution; even if a biosimilar exists, it may not be interchangeable.

If you want, I can help interpret current search results or guide you to the exact page and fields to look at.



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