Fda purple book dupilumab biosimilar approved 2025?

Short answer:
No—there isn’t a dupilumab biosimilar listed in the FDA’s Purple Book for 2025. As of the latest update (mid‑2024), no dupilumab biosimilar has received FDA approval, and the earliest approvals are still projected to be in the 2026 – 2027 window, depending on the review pace.

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What the Purple Book is and how it works

• Purple Book – a public database that the FDA maintains to list all biologic drugs and their approved biosimilar or interchangeable counterparts.
  
• Updates – The database is refreshed every few weeks as the FDA processes new approvals or adds new listings.
  
• What “approved” means – For a biosimilar, “approved” means the FDA has granted a biologic license application (BLA) and the product can be marketed.
  
  

Dupilumab and the current biosimilar landscape

| Company | Application status (as of 2024) | Expected review timeline |
|---------|----------------------------------|---------------------------|
| Amgen (Dupixent™ biosimilar) | Submitted BLA (2023) | Under FDA review; typical review is ~12–18 months |
| Other applicants (e.g., Amgen’s “dupixumab” concept) | Pending/withdrawn | Uncertain; no clear filing yet |

Because dupilumab is a relatively new biologic (approved 2017 for atopic dermatitis, 2018 for asthma, 2022 for chronic rhinosinusitis with nasal polyps), the regulatory pathway for its biosimilars is still unfolding. Most biosimilar applicants file a BLA and undergo the full FDA review cycle, which can take 18–24 months from submission.

Why 2025 hasn’t seen an approval yet

1. Review backlog – The FDA has a backlog of biologic approvals, especially in the first‑year window after a new biologic hits the market.
   
2. Safety & efficacy data – Biosimilar applicants must submit comprehensive comparability data. The Amgen submission, for instance, is still undergoing the data‑review phase.
   
3. Strategic timing – Applicants sometimes delay filing to align with their own commercial strategy or to coordinate with patent expiration events.
   
   

Where to keep track

• FDA Purple Book – https://www.accessdata.fda.gov/scripts/cder/purbl/
  
• FDA Biologics Database – The “Biologics License” section provides detailed status on BLAs.
  
• Industry news – Pharmaceutical trade publications (e.g., BioPharma Dive, PharmaTimes) often announce pending approvals.
  
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Bottom line

• No dupilumab biosimilar is listed in the Purple Book for 2025.
  
• The earliest potential approvals are still projected to arrive in 2026 or later, pending completion of the FDA review of the Amgen application (and any others that may file).
  
  If you need real‑time confirmation, check the Purple Book directly or set a Google Alert for “dupilumab biosimilar approval” to catch any new updates as soon as they’re posted.